PMA P100041S040
- Device
- Edwards Sapien Transcatheter Heart Valve And Acces
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- PMA number
- P100041
- Supplement
- S040
- Decision date
- 2013-10-11
Current openFDA PMA Record
- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES-RETROFLEX 3 DELIVERY SYSTEM, EDWARDS TRANSFEMORAL BALLOON CATHE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S040
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2013-10-11
- Decision code
- OK30
- Date received
- 2013-09-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A NEW STERILE WIPER FOR USE IN CLEANROOMS AND NON-CONTROLLED ENVIRONMENTS TO CLEAN WORK SURFACES AND TOOLS.