PMA P940008S031
- Device
- RES-Q ACD (ARRHYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTMY LEAD (NTL) SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P940008
- Supplement
- S031
- Product code
- LWS
- Decision date
- 2014-05-07
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- ADD AN IDENTICAL STERILIZATION CHAMBER TO THE ST. PAUL MANUFACTURING FACILITY.
Current openFDA PMA Record
- Device
- RES-Q ACD (ARRHYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTMY LEAD (NTL) SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P940008
- Supplement
- S031
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-05-07
- Decision code
- OK30
- Date received
- 2014-04-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD AN IDENTICAL STERILIZATION CHAMBER TO THE ST. PAUL MANUFACTURING FACILITY.