|
Device | CADENCE (R) TIERED THERAPY DEFIBRILLATOR SYSTEM |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S079 |
Date Received | 04/22/2005 |
Decision Date | 05/09/2005 |
Product Code |
DXY |
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 ALTERNATE PROCESS FOR REMOVING EPOXY FROM THE CONNECTOR BLOCK THREADED BORES OF THE ICD DEVICES. |