|
Device | CONTAK RENEWAL 1/3/3HE CRT-D DEVICES |
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 | S036 |
Date Received | 11/02/2004 |
Decision Date | 03/23/2007 |
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 |
Approval Order Statement APPROVAL FOR THE CONSULT SOFTWARE MODEL 2845 V2.10 TO BE USED TO ENABLE THE ABILITY TO PROGRAM THE V-V TIMING INTERVAL IN THE CONTAK RENEWAL MODEL H135; CONTAK RENEWAL 2 MODELS H170 AND 175; AND CONTAK RENEWAL 3 HE MODELS H177 AND H179 CRT-D DEVICES. |