|
Device | VENTAK AV AND VENTAK PRIZM DR/VR AICDS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S030 |
Date Received | 12/12/2002 |
Decision Date | 03/21/2003 |
Product Codes |
KRG 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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR CHANGES TO THE PATIENT HANDBOOKS. |