PUNCTUA, ENERGEN, INCEPTA, AND TELIGEN ICD
FDA premarket approval P960040/S297 · decided 2013-12-23
Approval details
- PMA number
- P960040
- Supplement
- S297
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PUNCTUA, ENERGEN, INCEPTA, AND TELIGEN ICD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.