CONSULTA CRT-P, SYNCRA CRT-P
FDA premarket approval P010015/S183 · decided 2012-12-12
Approval details
- PMA number
- P010015
- Supplement
- S183
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONSULTA CRT-P, SYNCRA CRT-P
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2012-11-15
- Decision date
- 2012-12-12
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATES TO THE FINAL TEST APPLICATION.
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510(k) clearances by this applicant
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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