PMA P110021S013
- Device
- RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDWARDS TRANSFEMORAL BALLOON CATHETER, CRIMPER, ASCENDRA BALLOO
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S013
- Product code
- NPT
- Decision date
- 2013-05-22
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- 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.
Current openFDA PMA Record#
- Device
- RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDWARDS TRANSFEMORAL BALLOON CATHETER, CRIMPER, ASCENDRA BALLOO
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S013
- 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)
- 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.