ON-X (R) PROSTHETIC HEART VALVE, ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, ON-X AORTIC PROSTHETIC HEART VALVE WITH A
FDA premarket approval P000037/S048 · decided 2017-02-07
Approval details
- PMA number
- P000037
- Supplement
- S048
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- ON-X (R) PROSTHETIC HEART VALVE, ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, ON-X AORTIC PROSTHETIC HEART VALVE WITH A
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- On-X Life Technologies, Inc.
- Date received
- 2016-12-09
- Decision date
- 2017-02-07
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for multiple changes, including clinical changes to the current protocol for the post-approval study (PAS) protocol.
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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 |