ON-X PROSTHETIC HEART VALVE
FDA premarket approval P000037/S030 · decided 2015-04-01
Approval details
- PMA number
- P000037
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ON-X PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- On-X Life Technologies, Inc.
- Date received
- 2012-10-23
- Decision date
- 2015-04-01
- Days to decision
- 890 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR A LABELING CHANGE TO ALLOW AORTIC VALVE REPLACEMENT PATIENTS TO BE TREATED USING A LOWERED ANTICOAGULATION TARGET.
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 |