PMA P060038S024
- Device
- MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
- Applicant
- Corcym Canada Corp
- PMA number
- P060038
- Supplement
- S024
- Product code
- LWR
- Decision date
- 2015-11-24
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- APPROVAL FOR REVISIONS TO THE MRI SAFETY LABELING.
Current openFDA PMA Record#
- Device
- MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
- Applicant
- Corcym Canada Corp
- PMA number
- P060038
- Supplement
- S024
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2015-11-24
- Decision code
- APPR
- Date received
- 2015-09-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISIONS TO THE MRI SAFETY LABELING.