PMA P150048S026
- Device
- Edwards Pericardial Mitral Bioprosthesis
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S026
- Product code
- LWR
- Decision date
- 2018-11-05
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Edwards Pericardial Mitral Bioprosthesis
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S026
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2018-11-05
- Decision code
- APPR
- Date received
- 2018-09-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.