PMA P960040S410
- Device
- NG3 Implantable Cardiac Defibrillators (ICDs): AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 ICDs: MOMENTUM, VIGILANT, PERCIV
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S410
- Product code
- LWS
- Decision date
- 2017-12-11
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Modifications to a suppliers cleaning process used in the manufacture of the MICS module component of the pulse generators hybrid.
Current openFDA PMA Record#
- Device
- NG3 Implantable Cardiac Defibrillators (ICDs): AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 ICDs: MOMENTUM, VIGILANT, PERCIV
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S410
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-12-11
- Decision code
- OK30
- Date received
- 2017-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to a suppliers cleaning process used in the manufacture of the MICS module component of the pulse generators hybrid.