INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES
FDA premarket approval P960040/S253 · decided 2012-03-30
Approval details
- PMA number
- P960040
- Supplement
- S253
- Supplement type
- 30-Day Notice
- Trade name
- INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-03-01
- Decision date
- 2012-03-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- REMOVE AN INSERTION FORCE PROCESS MONITOR.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.