PUNCTUA, ENERGEN INCEPTA COGNIS
FDA premarket approval P010012/S332 · decided 2013-12-23
Approval details
- PMA number
- P010012
- Supplement
- S332
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PUNCTUA, ENERGEN INCEPTA COGNIS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2013-06-17
- Decision date
- 2013-12-23
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE BATTERY FEEDTHRU (FT) MATERIALS OF THE DEVICE.
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