|
Device | VENTRITEX CONTOUR II/MD TIERED THERAPY IMPLANTABLE DEFIBRILLATOR |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S041 |
Date Received | 03/31/1999 |
Decision Date | 04/19/1999 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for an extension of the shelf life from 9 months to 18 months for the Contour(R) MD Model V-175 and the Contour(R) II Model V-185 Implantable Cardioverter Defibrillators. |