PMA P100041S056
- Device
- Sapien Thv With Retroflex For Inoperable Patients
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- PMA number
- P100041
- Supplement
- S056
- Decision date
- 2014-08-28
Current openFDA PMA Record
- Device
- SAPIEN THV WITH RETROFLEX FOR INOPERABLE PATIENTS AND WITH RETROFLEX OR ASCENDRA FOR HIGH RISK OPERABLE
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P100041
- Supplement
- S056
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2014-08-28
- Decision code
- APPR
- Date received
- 2014-07-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.