|
Device | VENTRITEX CONTOUR II/MD; ANGSTROM II/MD; PROFILE 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 | S042 |
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 |
Approval Order Statement Approval for a labeling change to reflect compatibility of the Contour II/MD, Angstrom II/MD, and Profile II/MD implantable defibrillators with cellular phones. |