PMA P960040S392
- Device
- Implantable Cardioverter Defibrillator (ICD) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOMENTUM, VIGI
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S392
- Product code
- LWS
- Decision date
- 2017-06-06
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Alternate supplier for Titanium ribbon.
Current openFDA PMA Record#
- Device
- Implantable Cardioverter Defibrillator (ICD) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOMENTUM, VIGI
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S392
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-06-06
- Decision code
- OK30
- Date received
- 2017-05-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for Titanium ribbon.