Autogen, Dynagen, Inogen, Origen NG3 ICDs; Resonate, Vigilant, Perciva NG4 ICDs
FDA premarket approval P960040/S396 · decided 2017-07-25
Approval details
- PMA number
- P960040
- Supplement
- S396
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- Autogen, Dynagen, Inogen, Origen NG3 ICDs; Resonate, Vigilant, Perciva NG4 ICDs
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2017-05-31
- Decision date
- 2017-07-25
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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