SOLO SMART STENTLESS HEART VALVE
FDA premarket approval P130011/S001 · decided 2015-07-22
Approval details
- PMA number
- P130011
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOLO SMART STENTLESS HEART VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2015-06-22
- Decision date
- 2015-07-22
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- MODIFICATION TO THE STERILIZATION PROCESS PARAMETERS, THE INCLUSION OF QUALITY CONTROL TESTS USED ON AN IN-PROCESS DEVICE, AND THE ADDITION OF BATCH TESTING TO THE FINAL STORAGE SOLUTION OF THE SOLO SMART HEART VALVE.
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