ON-X PROSTHETIC HEART VALVE and On-X Ascending Aortic Prothesis
FDA premarket approval P000037/S046 · decided 2016-07-25
Approval details
- PMA number
- P000037
- Supplement
- S046
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ON-X PROSTHETIC HEART VALVE and On-X Ascending Aortic Prothesis
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- On-X Life Technologies, Inc.
- Date received
- 2016-07-11
- Decision date
- 2016-07-25
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Use of an additional Coordinate Measuring Machine for heart valve housing measurements.
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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 |