ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, MODEL ONXAC
FDA premarket approval P000037/S002 · decided 2002-10-11
Approval details
- PMA number
- P000037
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, MODEL ONXAC
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- On-X Life Technologies, Inc.
- Date received
- 2002-04-16
- Decision date
- 2002-10-11
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR A MODIFIED AORTIC SEWING CUFF AS AN EXTENSION TO THE LINE OF AVAILABLE VALVES; THE REQUEST APPLIED TO THE AORTIC SIZES 19, 21, 23, 25, AND 27/29 MM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE AND WILL BE GIVEN THE MODEL DESIGNATION OF MODEL ONXAC AND 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 |