Solo Smart Stentless Heart Valve
FDA premarket approval P130011/S006 · decided 2018-03-07
Approval details
- PMA number
- P130011
- Supplement
- S006
- 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
- 2018-02-07
- Decision date
- 2018-03-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- Implementation of a new sterilization and neutralization (HCSTAN) system.
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