PMA P100041S055
- Device
- Edwards Sapien Transcather Heart Valve
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- PMA number
- P100041
- Supplement
- S055
- Decision date
- 2015-10-19
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S055
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2015-10-19
- Decision code
- APPR
- Date received
- 2014-07-17
- Supplement type
- 135 Review Track For 30-Day Notice
- Approval order statement
- APPROVAL FOR A MANUFACTURING LINE CHANGE AND THE USE OF AMMONIUM PERFLUOROOCTANOATE (APFO) FREE RESIN AT LENZING PLASTICS GMBH, AN EDWARDS APPROVED SUPPLIER.