THE SOLO SMART STENTLESS HEART VALVE
FDA premarket approval P130011/S003 · decided 2016-03-10
Approval details
- PMA number
- P130011
- Supplement
- S003
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THE SOLO SMART STENTLESS HEART VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2016-01-27
- Decision date
- 2016-03-10
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- Approval for extension of the allowable in-process permanence times for two solutions used in the manufacturing process.
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