PMA P790007S053
- Device
- Hancock Modified Orific Valved Conduit.
- Applicant
- Medtronic Heart Valves
- PMA number
- P790007
- Supplement
- S053
- Product code
- LWR
- Decision date
- 2017-10-03
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Reduction of the sample size for tissue microbial monitoring.
Current openFDA PMA Record#
- Device
- Hancock Modified Orific Valved Conduit.
- Applicant
- Medtronic Heart Valves
- PMA number
- P790007
- Supplement
- S053
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2017-10-03
- Decision code
- OK30
- Date received
- 2017-09-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction of the sample size for tissue microbial monitoring.