|
Device | CONTAK CD/CD2/RENEWAL/EASYTRAK |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S021 |
Date Received | 01/13/2004 |
Decision Date | 02/10/2004 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE. |