St. Jude touts CE Mark for next-gen high-energy ICD | Regulatory Roundup
510(k)
More warnings on metal-on-metal hip implants in U.K, New Zealand | Regulatory Roundup
Medtronic lands Canadian win for epilepsy therapy with brain stim | Regulatory Roundup
FDA releases March 510(k) clearances
March 2012 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINALDECISIONS RENDERED DURING THE PERIOD March 2012
DEVICE: OASYS SURGICAL LIGHT CONTROLLER
OASYS HEALTHCARE 510(k) NO: K112133(TRADITIONAL)
ATTN: TANYA M O'BRIEN PHONE NO : 813 645 2855
962 ALLEGRO LANE SE DECISION MADE: 01-MAR-12
APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FD TENS 2070
FUJI DYNAMICS LTD 510(k) NO: K111654(TRADITIONAL)
Abbott wins Xience Prime nod in Japan | Regulatory Roundup
Abbott (NYSE:ABT) said it won approval from the Japanese Ministry of Health, Labor and Welfare for its next-generation Xience Prime coronary stent
The nod means the cobalt-chromium stent is "available in all of the major markets worldwide," according to a press releaase, including the U.S., Europe, China and India.
GAO: FDA “inconsistent” in meeting performance goals
The FDA lacks consistency in review times for medical device pre-market approval applications, missing most goals for submissions marked "expedited," according to report by the Government Accountability Office.
"For FYs 2003 through 2010, FDA met most of the goals for original PMAs but fell short on most of the goals for expedited PMAs," according to the GAO report. "In addition, FDA review time and time to final decision for both types of PMAs generally increased during this period."
Zoll wins FDA nod for EMS AED | Regulatory Roundup
Zoll Medical (NSDQ:ZOLL) said it won 510(k) clearance from the for its ZOLL X monitor/defibrillator, a smaller, more powerful device aimed at the EMS market.
J&J responds on vaginal mesh controversy
Health care giant Johnson & Johnson (NYSE:JNJ) insists it followed appropriate regulatory guidance with its Gynecare Prolift transvaginal mesh product in the U.S. during the 3 years before obtaining FDA clearance.
Covidien touts 510(k) win for Nellcor respiration rate software
Covidien (NYSE:COV) landed an FDA win for its Nellcor respiration system with version 1.0 software and adult respiratory sensor.
The Mansfield, Mass.-based med-tech titan is preparing a limited market release in the U.S. next month, allowing select hospitals to use the Nellcor system, according to a press release.
Diabetes: Abbott lands FDA win for touch-screen glucose monitor | Regulatory Roundup
Steris gets FDA nod to update replacement for troubled System 1 sterilizers
Steris Corp. (NYSE:STE) landed special 510(k) clearance to modify its System 1E sterilizers, the replacement systems for the troubled System 1 devices that were the center of a 2-year row with the FDA.
The Mentor, Ohio-based device maker won the FDA’s approval to update existing SS1E devices in the field with modified software, which will also be applied to all new shipments, effective immediately.
