PMA P110021S031
- Device
- Edwards Sapien Transcatheter Heart Valve And Trans
- Applicant
- EDWARDS LIFESCIENCES LLC.
- PMA number
- P110021
- Supplement
- S031
- Decision date
- 2014-06-11
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S031
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2014-06-11
- Decision code
- APPR
- Date received
- 2013-10-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO AUTOMATE LABEL PRINTING, IMPLEMENT NEW PEEL STRENGTH EQUIPMENT, AND RELOCATE MANUFACTURING RADIO-FREQUENCY IDENTIFICATION TAGS.