SOLO SMART STENTLESS HEART VALVE (SOLO SMART)
FDA premarket approval P130011/S002 · decided 2016-02-09
Approval details
- PMA number
- P130011
- Supplement
- S002
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOLO SMART STENTLESS HEART VALVE (SOLO SMART)
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2015-12-07
- Decision date
- 2016-02-09
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- Approval for a change to the sterility testing of the final storage solution.
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