|
Device | PARAGON II AND PHOENIX PULSE GENERATORS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P830045 |
Supplement Number | S060 |
Date Received | 09/09/1998 |
Decision Date | 10/15/1998 |
Withdrawal Date
|
06/20/2007 |
Product Code |
LWP |
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 The 30-day Notice requested approval for use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products. |