PMA P940008S003
- Device
- RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P940008
- Supplement
- S003
- Decision date
- 1996-08-22
- Approval order 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
Current openFDA PMA Record
- Device
- RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P940008
- Supplement
- S003
- Decision date
- 1996-08-22
- Decision code
- APPR
- Date received
- 1996-02-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order 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