ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
FDA premarket approval P000037 · decided 2001-05-30
Approval details
- PMA number
- P000037
- Trade name
- ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- On-X Life Technologies, Inc.
- Date received
- 2000-09-01
- Decision date
- 2001-05-30
- Days to decision
- 271 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR THE ON-X. PROSTHETIC HEART VALVE, MODEL ONXA IN THE AORTIC POSITION INCLUDING SIZES 19, 21, 23, 25, AND 27/29 MM. THIS DEVICE IS INDICATED FOR REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC HEART VALVES IN THE AORTIC POSITION.
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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 |