PMA P960040S413
- Device
- ORIGEN / INOGEN / DYNAGEN /AUTOGEN /MOMENTUM /VIGILANT/ PERCIVA / RESONATE/ Implantable Cardioverter Defibrillator (ICD)
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S413
- Product code
- LWS
- Decision date
- 2017-12-06
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Modifications to the titanium can manufacturing process at the supplier.
Current openFDA PMA Record#
- Device
- ORIGEN / INOGEN / DYNAGEN /AUTOGEN /MOMENTUM /VIGILANT/ PERCIVA / RESONATE/ Implantable Cardioverter Defibrillator (ICD)
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S413
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-12-06
- Decision code
- OK30
- Date received
- 2017-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the titanium can manufacturing process at the supplier.