PMA P960040S400
- Device
- NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S400
- Product code
- LWS
- Decision date
- 2017-08-07
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S400
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-08-07
- Decision code
- APPR
- Date received
- 2017-07-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.