COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES
FDA premarket approval P010012/S300 · decided 2012-11-30
Approval details
- PMA number
- P010012
- Supplement
- S300
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2012-08-28
- Decision date
- 2012-11-30
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR SOFTWARE, FIRMWARE, AND HARDWARE ENHANCEMENTS AND MODIFICATIONS TO THE INCEPTA, ENERGEN, PUNCTUA, COGNIS, AND TELIGEN DEVICES.
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