MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX
FDA premarket approval P060038/S002 · decided 2009-02-27
Approval details
- PMA number
- P060038
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2008-12-29
- Decision date
- 2009-02-27
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- APPROVAL FOR MANUFACTURING PROCESS IMPROVEMENTS TO THE AORTIC PERICARDIAL HEART VALVE MODEL 12. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDE THE TRADE NAME MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
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