|
Device | VENTAK AV FAMILY (INCLUDES PRIZM AND VITALITY FAMILIES) |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S078 |
Date Received | 08/16/2005 |
Decision Date | 06/22/2012 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MINOR MANUFACTURE CHANGES OF THE DEVICES. |