|
Device | VENTAK VITALITY AVT AICD SYSTEM (MODEL A135) |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S042 |
Date Received | 01/21/2004 |
Decision Date | 03/19/2004 |
Product Codes |
KRG LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE SYSTEM GUIDE LABELING REINSERT (CHANGE TACHY MODE WITH MAGNET FEATURE). |