|
Device | CADENCE 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 | S075 |
Date Received | 09/08/2004 |
Decision Date | 01/19/2005 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR LABELING MODIFICATIONS TO DESCRIBE THE PROTOCOL AND RESULTS FROM THE DEFINITE CLINICAL TRIAL. |