PMA P010041S030
- Device
- S.A.V. BIOPROSTHESIS MODEL 2650 (AORTIC)
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2012-06-26
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL FOR THE LABELING CHANGE BASED ON THE POST-APPROVAL STUDY DATA.
Current openFDA PMA Record
- Device
- S.A.V. BIOPROSTHESIS MODEL 2650 (AORTIC)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P010041
- Supplement
- S030
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2012-06-26
- Decision code
- APPR
- Date received
- 2012-02-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR THE LABELING CHANGE BASED ON THE POST-APPROVAL STUDY DATA.