PMA P100028S002
- Device
- FORMULA BALLOOL-EXPANDABLE RENAL STENT SYSTEM
- Applicant
- Cook Medical Incorporated
- PMA number
- P100028
- Supplement
- S002
- Product code
- NIN
- Decision date
- 2012-04-30
- Generic name
- STENT, RENAL
- Approval order statement
- APPROVAL FOR THE 4 MM VERSION OF THE STENT TO BE USED WITH THE FORMULA 414 RX DELIVERY SYSTEM.
Current openFDA PMA Record#
- Device
- FORMULA BALLOOL-EXPANDABLE RENAL STENT SYSTEM
- Applicant
- Cook Medical Incorporated
- PMA number
- P100028
- Supplement
- S002
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2012-04-30
- Decision code
- APPR
- Date received
- 2012-02-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE 4 MM VERSION OF THE STENT TO BE USED WITH THE FORMULA 414 RX DELIVERY SYSTEM.