PMA P100041S027
- Device
- Retroflex 3 Delivery System, Retroflex Ballon Cath
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- PMA number
- P100041
- Supplement
- S027
- Decision date
- 2013-05-22
Current openFDA PMA Record
- Device
- RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLON CATHETER, EDWARDS TRANSFEMORAL BALLON CATHETER, CRIMPER
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S027
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2013-05-22
- Decision code
- APPR
- Date received
- 2013-04-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ADDITION OF POLYETHYLENE FOAM TO THE BASE OF THE CRIMPER DURING PACKAGING, A CHANGE TO THE CRIMPER PACKAGE RELEASE TEMPERATURE SET POINT, AND ADDITION OF POUCH INTEGRITY INSPECTIONS FOR ALL SAPIEN ACCESSORIES.