ATS OPEN PIVOT BILEAFLET HEART VALVE
FDA premarket approval P990046/S007 · decided 2003-08-01
Approval details
- PMA number
- P990046
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATS OPEN PIVOT BILEAFLET HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2003-05-20
- Decision date
- 2003-08-01
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A CUFF DESIGN CHANGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATS OPEN PIVOT BILEAFLET HEART VALVE, APEX AORTIC MODELS 503DA16, 503DA18, 503DA20, 503DA22, 503DA24, 503DA26, AND 503DA28, AND APEX MITRAL MODELS 503DM24, 503DM26, AND 503DM28 AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC OR MITRAL VALVES.
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