MITROFLOW AORTIC PERICARDIAL HEART VALVE
FDA premarket approval P060038/S005 · decided 2009-08-07
Approval details
- PMA number
- P060038
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MITROFLOW AORTIC PERICARDIAL HEART VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2009-07-08
- Decision date
- 2009-08-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- CHANGE IN THE MINIMUM EXPOSURE TIME FOR THE STERILIZATION PROCESS OF THE DEVICE.
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