PMA P940008S001
- Device
- Res-q(tm) Arrhythmia Control Device Systems
- Applicant
- BOSTON SCIENTIFIC
- PMA number
- P940008
- Supplement
- S001
- Decision date
- 1996-03-21
Current openFDA PMA Record
- Device
- RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P940008
- Supplement
- S001
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1996-03-21
- Decision code
- APPR
- Date received
- 1995-09-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE STERILIZATION PROCESS