CONSULTA AND SYNCRA CRT-P'S
FDA premarket approval P010015/S210 · decided 2013-08-12
Approval details
- PMA number
- P010015
- Supplement
- S210
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONSULTA AND SYNCRA CRT-P'S
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Medtronic, Inc.
- Date received
- 2013-07-17
- Decision date
- 2013-08-12
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE FOR AN INCOMING MATERIAL ACCEPTANCE PROCEDURE FOR UNDERFILL CURE EPOXY.
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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