On-X Prosthetic Heart Valve, Model Onxa
FDA premarket approval P000037/S052 · decided 2018-10-18
Approval details
- PMA number
- P000037
- Supplement
- S052
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- On-X Prosthetic Heart Valve, Model Onxa
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- On-X Life Technologies, Inc.
- Date received
- 2018-09-20
- Decision date
- 2018-10-18
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for the addition of an inspection to verify suture orientation marks.
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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 |