TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES
FDA premarket approval P960040/S254 · decided 2012-03-28
Approval details
- PMA number
- P960040
- Supplement
- S254
- Supplement type
- 30-Day Notice
- Trade name
- TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-03-01
- Decision date
- 2012-03-28
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- USE OF A NEW INSULATOR TAPE USED IN THE HIGH VOLTAGE CAPACITOR.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.