|
Device | VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S018 |
Date Received | 08/30/1996 |
Decision Date | 05/06/1997 |
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 |
Approval Order Statement APPROVAL FOR RHYTHMLINE(TM) TRANSTELEPHONIC INTERROGATION SYSTEM WHICH WILL PROVIDE REMOTE INTERROGATION AND DATA RETRIEVAL AND ECG MONITORING OF PATIENTS WITH VENTAK PRX II AND PRX III PULSE GENERATORS. |