PMA P960040S427
- Device
- DYNAGEN MINI, INOGEN MINI, ORIGEN MINI and PERCIVA MINI
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S427
- Product code
- LWS
- Decision date
- 2018-07-11
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Vertical integration for the Mini high voltage capacitor can manufacturing process.
Current openFDA PMA Record#
- Device
- DYNAGEN MINI, INOGEN MINI, ORIGEN MINI and PERCIVA MINI
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S427
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-07-11
- Decision code
- OK30
- Date received
- 2018-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Vertical integration for the Mini high voltage capacitor can manufacturing process.