MITROFLOW AORTIC PERICARDIAL HEART VALVE
FDA premarket approval P060038/S010 · decided 2011-12-12
Approval details
- PMA number
- P060038
- Supplement
- S010
- Supplement type
- 135 Review Track For 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
- 2011-07-22
- Decision date
- 2011-12-12
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- APPROVAL FOR IMPLEMENTATION OF AN IN-HOUSE DISTILLATION PROCESS TO PRODUCE EM GRADE LUTARALDEHYDE TO BE USED IN THE MANUFACTURE OF THE SUBJECT DEVICE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.