MITROFLOW AORTIC PERICARDIAL HEART VALVE
FDA premarket approval P060038/S025 · decided 2015-10-12
Approval details
- PMA number
- P060038
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MITROFLOW AORTIC PERICARDIAL HEART VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2015-09-28
- Decision date
- 2015-10-12
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- APPROVAL FOR EXTENDING THE SHELF LIFE FOR THE DEVICE FROM ONE YEAR TOTWO YEARS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.