CADENCE FAMILY OF ICDS
FDA premarket approval P910023/S270 · decided 2012-03-09
Approval details
- PMA number
- P910023
- Supplement
- S270
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CADENCE FAMILY OF ICDS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-07-19
- Decision date
- 2012-03-09
- Days to decision
- 234 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE ADDITION OF THE CORVUE THORACIC IMPEDANCE MONITORING FEATURE IN THE UNIFY, FORTIFY AND QUADRA FAMILY OF DEVICES.
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510(k) clearances by this applicant
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| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |