|
Device | CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS |
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 | S131 |
Date Received | 05/12/2006 |
Decision Date | 08/25/2006 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR PRODUCT RELIABILITY TEST TO BE ADDED TO THE PHYSICIAN AND PATIENT LABELING AS WELL AS OTHER MINOR CHANGES TO THE PATIENT MANUALS. |