On-X Ascending Aortic Prosthesis
FDA premarket approval P000037/S056 · decided 2021-10-13
Approval details
- PMA number
- P000037
- Supplement
- S056
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- On-X Ascending Aortic Prosthesis
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- On-X Life Technologies, Inc.
- Date received
- 2020-04-15
- Decision date
- 2021-10-13
- Days to decision
- 546 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for several changes to the On-X Ascending Aortic Prosthesis including changes to the yarn and gelatin component manufacturing and changes to device labeling.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT (K141060) | On-X Life Technologies, Inc. | 2014-06-06 |