PMA P150048S001
- Device
- Edwards Pericardial Aortic Bioprosthesis
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S001
- Product code
- LWR
- Decision date
- 2017-09-21
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval for revisions to the protocol for the ODE lead post-approval study (PAS).
Current openFDA PMA Record#
- Device
- Edwards Pericardial Aortic Bioprosthesis
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S001
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2017-09-21
- Decision code
- APPR
- Date received
- 2017-07-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for revisions to the protocol for the ODE lead post-approval study (PAS).