|
Device | VENTAK AV /PRIZM/ VITALITY |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S135 |
Date Received | 11/01/2006 |
Decision Date | 02/08/2007 |
Product Code |
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 GUIDANT PULSE GENERATOR REPLACEMENT GUIDE WHICH PROVIDES IMPLANTING PHYSICIANS WITH GENERAL ADVICE ABOUT REMOVAL AND REPLACEMENT OF PULSE GENERATORS REACHING END OF LIFE. |