ON-X PROSTHETIC HEART VALVE
FDA premarket approval P000037/S037 · decided 2015-02-09
Approval details
- PMA number
- P000037
- Supplement
- S037
- Supplement type
- Normal 180 Day 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
- 2014-08-27
- Decision date
- 2015-02-09
- Days to decision
- 166 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR MODIFIED DEVICE PACKAGING AND AN EXTENSION TO THE PRODUCT SHELF LIFE.
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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 |