|
Device | VENTAK AV DDD FAMILY OF AICD SYSTEMS |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S005 |
Date Received | 01/22/1998 |
Decision Date | 02/02/1998 |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes in the VENTAK(R) AV II Physician's Manual and Device Warranty. |