Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen ICD Devices
FDA premarket approval P960040/S389 · decided 2017-04-21
Approval details
- PMA number
- P960040
- Supplement
- S389
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen ICD Devices
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2017-02-17
- Decision date
- 2017-04-21
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a software update to improve the boot up process.
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