PMA P960040S419
- Device
- DYNAGEN EL/MINI; INOGEN EL/MINI; ORIGEN EL/MINI; AUTOGEN EL; VIGILIANT EL; PERCIVA; RESONATE EL/HF; PERCIVA HF; MOMENTUM
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S419
- Product code
- LWS
- Decision date
- 2018-02-08
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- New controlled environment area (CEA) level VIII for battery testing.
Current openFDA PMA Record#
- Device
- DYNAGEN EL/MINI; INOGEN EL/MINI; ORIGEN EL/MINI; AUTOGEN EL; VIGILIANT EL; PERCIVA; RESONATE EL/HF; PERCIVA HF; MOMENTUM
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S419
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-02-08
- Decision code
- OK30
- Date received
- 2018-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New controlled environment area (CEA) level VIII for battery testing.