MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
FDA premarket approval P060038/S024 · decided 2015-11-24
Approval details
- PMA number
- P060038
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2015-09-22
- Decision date
- 2015-11-24
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- APPROVAL FOR REVISIONS TO THE MRI SAFETY LABELING.
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