COGNIS CARDIAC RESYNCHRONIZATION HIGH ENERGY DEFIBRILLATOR
FDA premarket approval P010012/S179 · decided 2008-05-08
Approval details
- PMA number
- P010012
- Supplement
- S179
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COGNIS CARDIAC RESYNCHRONIZATION HIGH ENERGY DEFIBRILLATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2008-04-30
- Decision date
- 2008-05-08
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR UPDATES TO THE PROGRAMMER SW MODEL 2868 V1.02 AND PULSE GENERATOR FIRMWARE V1.04.0, PATCH V1.00 FOR THE TELIGEN AND COGNIS FAMILIES OF DEVICES.
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