|
Device | VENTRITEX(R) TVL(R) LEAD SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P950022 |
Supplement Number | S009 |
Date Received | 06/08/2000 |
Decision Date | 07/06/2000 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE TVL RIGHT VENTRICULAR (RV) LEAD MODELS RV06 AND RV07. |