|
Device | VENTAK PRX AICD SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S108 |
Date Received | 08/23/2010 |
Decision Date | 09/14/2010 |
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 CHANGES TO THE MODEL 3120 PROGRAMMER SYSTEM SOFTWARE MODEL 2909 FROM VERSION 6.01 TO VERSION 7.01. |