On-X Ascending Aortic Prosthesis
FDA premarket approval P000037/S051 · decided 2017-12-14
Approval details
- PMA number
- P000037
- Supplement
- S051
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- On-X Ascending Aortic Prosthesis
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- On-X Life Technologies, Inc.
- Date received
- 2017-07-05
- Decision date
- 2017-12-14
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for an additional ethylene oxide sterilization site located at 1300 East Anderson Lane, Building B, Austin, Texas.
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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 |