PMA P010041S001
- Device
- CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- Product code
- DYE
- Decision date
- 2003-01-17
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
Current openFDA PMA Record
- Device
- CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P010041
- Supplement
- S001
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2003-01-17
- Decision code
- APPR
- Date received
- 2002-07-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.