INCEPTA, ENERGEN AND PUNTUA IDCS
FDA premarket approval P960040/S255 · decided 2012-04-11
Approval details
- PMA number
- P960040
- Supplement
- S255
- Supplement type
- 30-Day Notice
- Trade name
- INCEPTA, ENERGEN AND PUNTUA IDCS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-03-13
- Decision date
- 2012-04-11
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE TO THE THERMAL PROCESSING OF COMPONENTS AND A CHANGE IN SUPPLIERS.
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