PMA P790007S060
- Device
- Hancock Valved Conduit LP
- Applicant
- Medtronic Heart Valves
- PMA number
- P790007
- Supplement
- S060
- Product code
- LWR
- Decision date
- 2019-03-03
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Use of a new compressed air system during heart valve manufacturing.
Current openFDA PMA Record#
- Device
- Hancock Valved Conduit LP
- Applicant
- Medtronic Heart Valves
- PMA number
- P790007
- Supplement
- S060
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2019-03-03
- Decision code
- OK30
- Date received
- 2019-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of a new compressed air system during heart valve manufacturing.