FREEDOM SOLO STENTLESS HEART VALVE
FDA premarket approval P130011 · decided 2014-06-24
Approval details
- PMA number
- P130011
- Trade name
- FREEDOM SOLO STENTLESS HEART VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2013-05-13
- Decision date
- 2014-06-24
- Days to decision
- 407 days
- Decision code
- APWD
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- APPROVAL FOR THE FREEDOM SOLO STENTLESS HEART VALVE AND SOLO SMART STENTLESS HEART VALVE. THESE DEVICES ARE INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETICAORTIC VALVES.
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