PMA P960040S415
- Device
- DYNAGEN, INOGEN, ORIGEN, AUTOGEN EL ICD; DYNAGEN MINI, INOGEN MINI, ORIGEN MINI ICD; INCEPTA, ENERGEN, PUNCTUA ICD; MOME
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S415
- Product code
- LWS
- Decision date
- 2018-01-10
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add an alternate supplier of titanium ribbon.
Current openFDA PMA Record#
- Device
- DYNAGEN, INOGEN, ORIGEN, AUTOGEN EL ICD; DYNAGEN MINI, INOGEN MINI, ORIGEN MINI ICD; INCEPTA, ENERGEN, PUNCTUA ICD; MOME
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S415
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-01-10
- Decision code
- OK30
- Date received
- 2017-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate supplier of titanium ribbon.