ATS OPEN PIVOT BILEAFLET HEART VALVE
FDA premarket approval P990046 · decided 2000-10-13
Approval details
- PMA number
- P990046
- Trade name
- ATS OPEN PIVOT BILEAFLET HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 1999-07-29
- Decision date
- 2000-10-13
- Days to decision
- 442 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE ATS OPEN PIVOT BILEAFLET HEART VALVE, STANDARD AORTIC MODEL A500FA 21, 23, 25, 27, AND 29 MM, STANDARD MITROAL MODEL 500DM 29, 31, AND 33 MM, ADVANCED PERFORMANCE (AP) AORTIC MODEL 501DA 18, 20, 22, 24, AND 26 MM, AND AP MITRAL MODEL 510DM 26 AND 28 MM. THE DEVICE IN INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC OR MITRAL VALVES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.