|
Device | CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S045 |
Date Received | 08/30/1999 |
Decision Date | 09/27/1999 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to implement a minor manufacturing change (increase in the number of Kapton layers between the high voltage capacitors) in the Contour and Angstrom implantable defibrillators. |