PMA P960040S416
- Device
- Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate, Perciva,Punctua, Energen, Incepta ICD
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S416
- Product code
- LWS
- Decision date
- 2018-01-19
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Additional supplier of nickel materials used in the battery stack sub-assemblies.
Current openFDA PMA Record#
- Device
- Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate, Perciva,Punctua, Energen, Incepta ICD
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S416
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-01-19
- Decision code
- OK30
- Date received
- 2017-12-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional supplier of nickel materials used in the battery stack sub-assemblies.