PMA P110021S042
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S042
- Product code
- NPT
- Decision date
- 2015-10-19
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- 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.
Current openFDA PMA Record#
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S042
- 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.