|
Device | VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S117 |
Date Received | 03/06/2006 |
Decision Date | 04/05/2006 |
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 UPDATES TO THE SPECIFICATIONS OF THE DEVICES REGARDING CONFIRMATION OF MEETING HERMETIC AND ARC SUPPRESSION UNDER HIGH VOLTAGE REQUIREMENTS RELATED TO THE ATMOSPHERIC GAS WITHIN THE DEVICE. |