Crown PRT Aortic Pericardial Heart Valve with PR Treatment
FDA premarket approval P060038/S026 · decided 2016-01-13
Approval details
- PMA number
- P060038
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Crown PRT Aortic Pericardial Heart Valve with PR Treatment
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2015-11-04
- Decision date
- 2016-01-13
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL DL, NAMELY THE ADDITION OF RADIOGRAPHIC MARKERS ON THE SEWING RING AND ADDITION OF VISIBLE MARKERS ON THE SEWING CUFF. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CROWN PRT AORTIC PERICARDIAL HEART VALVE WITH PR TREATMENT AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.
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