RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
FDA premarket approval P940008/S003 · decided 1996-08-22
Approval details
- PMA number
- P940008
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
- Applicant
- Boston Scientific
- Date received
- 1996-02-20
- Decision date
- 1996-08-22
- Days to decision
- 184 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO CONSIDER THE INFORMATION PROVIDED IN THIS SUPPLEMENT AS AN ALTERNATIVE RESPONSE TO THE CONDITIONS OF APPROVAL SET FORTH IN THE FDA LETTER DATED NOVEMBER 7, 1995. THE CONDITION REQUIRED THAT REMAINING MINOR SOFTWARE ANOMALIES BE CORRECTED
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