ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
FDA premarket approval P000037/S050 · decided 2017-12-05
Approval details
- PMA number
- P000037
- Supplement
- S050
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- On-X Life Technologies, Inc.
- Date received
- 2017-01-25
- Decision date
- 2017-12-05
- Days to decision
- 314 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for an additional manufacturing lathe and a new coolant for the leaflet substrate grinding process.
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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 |