|
Device | RENEWAL 3 RF ICDS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S054 |
Date Received | 10/11/2005 |
Decision Date | 12/02/2005 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODEL 6482 COMMUNICATOR LATITUDE WITH APPLICATION V1.6 AND SYSTEM APPLICATION SOFTWARE (SAS) WITH APPLICATION V1.1.1. |