- Device
- Hancock Modified Orifice Valved Conduit
- Applicant
- Medtronic Heart Valves
- PMA number
- P790007
- Supplement
- S052
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2017-12-13
- Decision code
- APPR
- Date received
- 2017-08-14
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a transfer of manufacturing operations to a new controlled environment area within the same manufacturing site.