ON-X PROSTHETIC HEART VALVE
FDA premarket approval P000037/S014 · decided 2008-10-09
Approval details
- PMA number
- P000037
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ON-X PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- On-X Life Technologies, Inc.
- Date received
- 2008-08-22
- Decision date
- 2008-10-09
- Days to decision
- 48 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- INTRODUCTION OF A SECOND D-OX CLEANING PROCESS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |