PMA P150048S012
- Device
- Edwards Pericardial Mitral Bioprosthesis, Model 11000M
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S012
- Product code
- LWR
- Decision date
- 2018-08-09
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval for the Edwards Pericardial Mitral Bioprosthesis, Model 11000M. This device is indicated for the replacement of native or prosthetic mitral heart valves.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf15/P150048S012B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- Edwards Pericardial Mitral Bioprosthesis, Model 11000M
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S012
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2018-08-09
- Decision code
- APPR
- Date received
- 2017-12-01
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the Edwards Pericardial Mitral Bioprosthesis, Model 11000M. This device is indicated for the replacement of native or prosthetic mitral heart valves.