|
Device | VENTRITEX HOUSECALL RECEIVER/TRANSMITTER |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S043 |
Date Received | 04/26/1999 |
Decision Date | 08/04/1999 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the transtelephonic follow-up system. The device, as modified, will be marketed under the trade name Housecall(TM) 2.0 system and is indicated for use with the Ventritex(R) Tiered-Therapy Defibrillators. |