RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
FDA premarket approval P940008/S002 · decided 1996-08-20
Approval details
- PMA number
- P940008
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1996-02-05
- Decision date
- 1996-08-20
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A SUPPLEMENT WHICH SATISFIES THE REQUIREMENT TO SUBMIT A POST-APPROVAL STUDY PROTOCOL FOR THE INTERMEDICS EPICARDIAL PATCH DEFIBRILLATION LEADS. THE POST APPROVAL STUDY WAS REQUIRED AS A CONIDTIN OF APPROVAL IN OUR LETTER DATED NOVEMBER 7, 1995
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