PMA P100028
- Device
- FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
- Applicant
- Cook Medical Incorporated
- PMA number
- P100028
- Supplement
- S004
- Product code
- NIN
- Decision date
- 2014-10-08
- Generic name
- STENT, RENAL
- Approval order statement
- APPROVAL FOR A LABELING UPDATE BASED ON THE POST-APPROVAL STUDY RESULTS.
Current openFDA PMA Record#
- Device
- FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
- Applicant
- Cook Medical Incorporated
- PMA number
- P100028
- Supplement
- S004
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2014-10-08
- Decision code
- APPR
- Date received
- 2013-09-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR A LABELING UPDATE BASED ON THE POST-APPROVAL STUDY RESULTS.