ON-X PROSTHETIC HEART VALVE
FDA premarket approval P000037/S001 · decided 2002-03-06
Approval details
- PMA number
- P000037
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ON-X PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- On-X Life Technologies, Inc.
- Date received
- 2001-09-07
- Decision date
- 2002-03-06
- Days to decision
- 180 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 ONXM IN SIZES 25 MM, 27/29 MM, 31/33 MM, AND MODEL ONXMC IN SIZE 25/33 MM IN THE MITRAL POSITION. THIS DEVICE IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC HEART VALVES IN THE MITRAL 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 |