Solo Smart Heart Valve
FDA premarket approval P130011/S008 · decided 2020-02-10
Approval details
- PMA number
- P130011
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Solo Smart Heart Valve
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2020-01-13
- Decision date
- 2020-02-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- Modification to the sealing ring of the primary packaging.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.