RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS
FDA premarket approval P940008 · decided 1995-11-28
Approval details
- PMA number
- P940008
- Trade name
- RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1994-03-17
- Decision date
- 1995-11-28
- Days to decision
- 621 days
- Decision code
- APWD
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL APPLICATION (PMA) FOR THE RES-Q ACD (ARRYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS WHICH CONSIST OF THE FOLLOWING: MODEL 101-01 & 101-01R RES-Q IMPLANTABLE ARRHYTHMIA CONTROL DEVICE; MODEL 531-30 RX2000 GRAPHICS PROGRAM MODULE TO BE USED WITH INTERMEDICS COMMERCIALLY AVAILABLE MODEL 522-06 RX2000 GRAPHICS PROGRAMMER; MODELS 497-05, 497-06, AND 497-09 RIGHT VENTRICULAR (RV) DEFIBRILLATION/PACING LEADS; MODEL 497-15 SUBCUTANEOUS PATCH LEAD; MODEL 497-16
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