|
Device | CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S050 |
Date Received | 12/19/2000 |
Decision Date | 01/18/2001 |
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 |
Approval Order Statement USE OF AN ALTERNATE STERILIZATION CHAMBER FOR THE ICDS AND TACHYCARDIA LEADS AND IS ALSO REQUESTING APPROVAL FOR USE OF PARAMETRIC RELEASE AS AN ALTERNATE TO THE CURRENT USE OF BIOLOGICAL INDICATORS IN THE RELEASE OF STERILIZED PRODUCTS. |