Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | CONTAK RENEWAL 3 RF/HE CRT-D,CONSULT PROGRAMMER SOFT WARE |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S031 |
Date Received | 08/18/2004 |
Decision Date | 02/09/2005 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF WANDLESS TELEMETRY TO YOUR CURRENTLY MARKET-APPROVED CRT-D DEVICES THAT WILL ALLOW COMMUNICATION WITH THE PROGRAMMER AT AN INCREASED DISTANCE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTAK RENEWAL 3 RF AND IS INDICATED FOR THE FOLLOWING: THE CONTAK RENEWAL 3 RF CRT-D IS INDICATED FOR PATIENTS WITH MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS. |
|
|