PMA P960040S429
- Device
- ICDs Autogen, Inogen, Dynagen, Origen, Resonate, Momentum, Vigilant, Perciva, Punctua, Energen, and Incepta
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S429
- Product code
- LWS
- Decision date
- 2018-10-10
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Changes to the battery assembly process sequence and parylene coating process.
Current openFDA PMA Record#
- Device
- ICDs Autogen, Inogen, Dynagen, Origen, Resonate, Momentum, Vigilant, Perciva, Punctua, Energen, and Incepta
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S429
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-10-10
- Decision code
- OK30
- Date received
- 2018-10-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the battery assembly process sequence and parylene coating process.