PUNTUA CRT-D , COGNIS, ENERGEN & INCEPTA CRT-D
FDA premarket approval P010012/S287 · decided 2012-05-03
Approval details
- PMA number
- P010012
- Supplement
- S287
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PUNTUA CRT-D , COGNIS, ENERGEN & INCEPTA CRT-D
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2012-03-30
- Decision date
- 2012-05-03
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE LABELING MODIFICATION OF THE DEVICE LONGEVITY TABLES FOR THE DEVICES.
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