|
Device | VENTAK PRX/ MINI III/ MINI IV |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S044 |
Date Received | 01/13/2004 |
Decision Date | 02/10/2004 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE. |