PMA P960040S422
- Device
- Implantable Cardioverter Defibrillator (ICD): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIG
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S422
- Product code
- LWS
- Decision date
- 2018-03-12
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Alternate test method system for battery electrolyte inspection.
Current openFDA PMA Record#
- Device
- Implantable Cardioverter Defibrillator (ICD): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIG
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S422
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-03-12
- Decision code
- OK30
- Date received
- 2018-02-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate test method system for battery electrolyte inspection.