Navigation Links
Hospira Submits 510(k) Application to FDA for Symbiq™ Infusion System Modifications
Date:4/4/2011

LAKE FOREST, Ill., April 4, 2011 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), a leading provider of clinical information and medication delivery technologies, today announced that the company has submitted a 510(k) application with the U.S. Food and Drug Administration (FDA) for modifications to the Symbiq™ infusion system. The submission is one of the first developed to align with the recent FDA draft guidance for 510(k) infusion pump clearances.

"With this submission complete, we are on track to meet our commitments for resuming new customer shipments of Symbiq infusion pumps and advancing the continuous evolution of one of the most innovative infusion platforms in the hospital today," said Sumant Ramachandra, M.D., Ph.D., senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira. "As one of the first companies to file an application under the draft FDA guidance for infusion pumps, we are looking forward to continuing to work with the Agency through this new and innovative regulatory process."

The 510(k) submission to FDA for clearance of the Symbiq infusion system version 3.11 identifies modifications Hospira has made to further enhance the reliability of the infusion pump.  In 2010, Hospira voluntarily placed shipments of the Symbiq pump on hold for customers, while the company finalized the proposed product upgrades. Hospira regularly communicates with current Symbiq customers regarding the status of the system modifications, and plans to upgrade all of the Symbiq infusion pumps currently in use once the FDA provides clearance.  Hospira submitted the 510(k) application to the FDA on March 31, 2011.

Hospir
'/>"/>

SOURCE Hospira, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Hospira Launches Enhanced TheraDoc™ Clinical Surveillance System to Support Patient Safety and Help Improve Care
2. Hologic, Hospira, Boston Scientific, Allergan to Participate in Leading Medical Device Manufacturing Symposium
3. Hospira Announces U.S. Approval of Generic Docetaxel
4. Hospira Board Names F. Michael Ball New CEO; Christopher B. Begley to Assume Executive Chairman Role
5. Hospira MedNet™ Portal Safety Software Benchmarking System Debuts at HIMSS
6. Hospira to Present at Upcoming Investor Conferences
7. Hospira Announces FDA Approval of Topotecan Injection
8. Hospira Reports Fourth-Quarter and Full-Year 2010 Results
9. Hospira to Host Conference Call for Fourth-Quarter 2010 Results and 2011 Projections
10. Hospira Launches Piperacillin and Tazobactam for Injection in the United States
11. Hospira Announces New Contracts in Effect with Novation for Infusion Pumps, Solutions and Equipment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/23/2014)... NOT FOR RELEASE, PUBLICATION OR ... INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD ... SUCH JURISDICTION. AbbVie (NYSE: ABBV ) ... 25, 2014, before the market opens. AbbVie will ... 8 a.m. Central time (9 a.m. Eastern). It will be ...
(Date:7/23/2014)... 23, 2014 Research and Markets ... "Global Electrophysiology Ablation Catheters Market 2014-2018" report ... http://photos.prnewswire.com/prnh/20130307/600769 Catheter ablation is a ... faulty electrical pathways from sections of the heart ... cardiac arrhythmias). Cardiac arrhythmias can be of several ...
(Date:7/23/2014)...  Nonin Medical, Inc., the inventor of finger pulse ... today that Mark VanderWerf , Nonin,s Vice President ... the American Telemedicine Association,s (ATA) Industry Council and will ... ATA is the leading international resource and advocate promoting ... and its diverse membership work to transform healthcare to ...
Breaking Medicine Technology:AbbVie to Host Second-Quarter Earnings Conference Call 2AbbVie to Host Second-Quarter Earnings Conference Call 3AbbVie to Host Second-Quarter Earnings Conference Call 4AbbVie to Host Second-Quarter Earnings Conference Call 5AbbVie to Host Second-Quarter Earnings Conference Call 6Global Electrophysiology Ablation Catheters Market 2014-2018: Key Vendors are Boston Scientific, Johnson & Johnson, Medtronic and St. Jude Medical 2Global Electrophysiology Ablation Catheters Market 2014-2018: Key Vendors are Boston Scientific, Johnson & Johnson, Medtronic and St. Jude Medical 3Nonin Medical Announces that Mark VanderWerf has been Elected Chairman of the American Telemedicine Association's Industry Council 2
... Rochester Medical Implants ( http://www.rmi.us.com ), a contract manufacturer ... it has relocated corporate offices and manufacturing operations to ... the location change, the company will change its name ... The new facility is a modern 33,000-square ...
... Calif., Oct. 17, 2011 ChemoCentryx, Inc., today ... trial for CCX168, an orally-administered small molecule for ... (AAV), a disease which can lead to renal ... receptor (C5aR), a potent pro-inflammatory mediator that is ...
Cached Medicine Technology:Rochester Medical Implants Relocates to New Facility in Noblesville, IN 2ChemoCentryx Initiates Phase II Clinical Trial for CCX168, a Novel Small Molecule C5aR Antagonist for the Treatment of Vasculitis 2ChemoCentryx Initiates Phase II Clinical Trial for CCX168, a Novel Small Molecule C5aR Antagonist for the Treatment of Vasculitis 3ChemoCentryx Initiates Phase II Clinical Trial for CCX168, a Novel Small Molecule C5aR Antagonist for the Treatment of Vasculitis 4
(Date:7/23/2014)... 2014 (HealthDay News) --,Jealousy may not be the sole ... get downright possessive when it comes to the love ... toward what was actually a stuffed dog, the real ... the stuffed dog aside, report researchers from the University ... only surfaced when owners were attending to the stuffed ...
(Date:7/23/2014)... effort to catalog the molecular causes of stomach ... have identified four subtypes of tumors based on ... the new classification promises to advance clinical research ... killer worldwide. , In a report in ... Research Network said they analyzed 295 samples of ...
(Date:7/23/2014)... 2014 Texas Physical Therapy Specialists (TexPTS) ... their Westlake, Westgate, Liberty Hill, Parmer, Balcones, and Georgetown ... of Orthopaedic Certified Specialist (OCS) or ... PT, DPT, OCS, Tony Lauretta, PT, DPT, OCS, Jason ... Joseph Leech, PT, DPT, OCS, and Mary Grimberg, PT, ...
(Date:7/23/2014)... A therapy combining salmon fibrin injections into the spinal ... brain restored voluntary motor function impaired by spinal cord ... found. , In a study on rodents, Gail Lewandowski ... the developmental clock in a molecular pathway critical to ... a scaffold so that neuronal axons at the injury ...
(Date:7/23/2014)... North American market was valued at $985.4 million in 2012. ... 10.79%, to reach $1,801.1 million by 2018. Organobromines is the ... Bromine Market report defines and segments the bromine market in ... the TOC of the North American Bromine Market report, to ... provides a glimpse of the segmentation in the North America ...
Breaking Medicine News(10 mins):Health News:Dogs Can Get Jealous, Too 2Health News:New view of stomach cancer could hasten better therapies 2Health News:New view of stomach cancer could hasten better therapies 3Health News:Texas Physical Therapy Specialists Congratulates New Board Certified Specialists 2Health News:Texas Physical Therapy Specialists Congratulates New Board Certified Specialists 3Health News:Gene inhibitor, salmon fibrin restore function lost in spinal cord injury 2Health News:North America Bromine Market is Expected to Reach $1801.1 million in 2018 - New Report by MicroMarket Monitor 2Health News:North America Bromine Market is Expected to Reach $1801.1 million in 2018 - New Report by MicroMarket Monitor 3Health News:North America Bromine Market is Expected to Reach $1801.1 million in 2018 - New Report by MicroMarket Monitor 4
... ... drug efficacy and reducing side effects , ... Santa Barbara, Calif. (Vocus) April 8, 2010 -- Researchers have ... penetrate deeply into tumor tissue. The peptide has been shown to substantially increase treatment ...
... effective as blood thinner, study finds , THURSDAY, April 8 ... works as well as medication -- and is safer -- ... device is as useful as blood thinners for the reduction ... safety," said study co-author Dr. Douglas E. Padgett, chief of ...
... have resulted in extended and repeated combat-related deployments of U.S. ... problems, both physical and psychological, many bring back with them, ... home can have issues as well. The ... quickly adjust to altered family roles and the stress of ...
... can take in the waiting room may lead to ... News) -- A researcher has developed a brief ... suffering from the early memory and reasoning problems that ... the journal Alzheimer Disease and Associated Disorders , ...
... under Singapore,s Agency for Science, Technology and Research (A*STAR), ... (SIgN), are collaborating with Italy,s Siena Biotech S.p.A. to ... potentially help millions of cancer and bone loss patients ... collaboration A*STAR has with research centres and universities in ...
... others interested in the chemical sciences are invited to ... Society (ACS) Webinars, focusing on Professional Growth and Development. ... p.m. Eastern Time, the free webinar will feature Martin ... years of experience working on immigration visas for scientists, ...
Cached Medicine News:Health News:Research Reveals Cancer Drug Effectiveness Substantially Advanced 2Health News:Research Reveals Cancer Drug Effectiveness Substantially Advanced 3Health News:Research Reveals Cancer Drug Effectiveness Substantially Advanced 4Health News:Research Reveals Cancer Drug Effectiveness Substantially Advanced 5Health News: Compression Device May Outperform Meds After Hip Surgery 2Health News:Children of combat-deployed parents show increased worries, even after parent returns 2Health News:Simple Memory Test May Detect Early Alzheimer's 2Health News:Exploring the 'Davids and Goliaths' of therapeutic molecules 2Health News:Exploring the 'Davids and Goliaths' of therapeutic molecules 3Health News:ACS Webinar focuses on immigration law for scientific professionals 2
300 L, Bulk Recommended for 250 and 300 L pipettes. Can also be used with 20, 25, 50, 100 and 200 L pipette...
Its MicroPoint design and reference marks at 10, 50 and 100 L ensure accurate performance with a variety of multi-channel and single-channel pipettors....
... its wide orifice tip, the Finntip Wide ... suspensions and macromolecules like genomic DNA. This ... cell fragmentation. It is excellent for use ... model, the inside diameter of the orifice ...
MBP's equivalent to the "Universal Yellow" tip, this 200 ul tip utilizes a MicroPoint design for accurate sample handling. 10 L Ref. mark....
Medicine Products: