PMA P960040S396
- Device
- Autogen, Dynagen, Inogen, Origen NG3 ICDs; Resonate, Vigilant, Perciva NG4 ICDs
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S396
- Product code
- LWS
- Decision date
- 2017-07-25
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
Current openFDA PMA Record#
- Device
- Autogen, Dynagen, Inogen, Origen NG3 ICDs; Resonate, Vigilant, Perciva NG4 ICDs
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S396
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-07-25
- Decision code
- APPR
- Date received
- 2017-05-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB