Resonate, Momentum, Vigilant, Perciva, Autogen, Dynagen, Inogen, Origen Implantable Cardioverter Defibrillators
FDA premarket approval P960040/S459 · decided 2021-10-07
Approval details
- PMA number
- P960040
- Supplement
- S459
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Resonate, Momentum, Vigilant, Perciva, Autogen, Dynagen, Inogen, Origen Implantable Cardioverter Defibrillators
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2020-11-12
- Decision date
- 2021-10-07
- Days to decision
- 329 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for hardware, software, and firmware changes to NG3/NG4 Pulse Generators.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.