PMA P100028S003
- Device
- FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
- Applicant
- Cook Medical Incorporated
- PMA number
- P100028
- Supplement
- S003
- Product code
- NIN
- Decision date
- 2014-03-28
- Generic name
- STENT, RENAL
- Approval order statement
- APPROVAL FOR AN ADDITIONAL DELIVERY SYSTEM (FORMULA 535 DELIVERY SYSTEM) FOR THE FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM.
Current openFDA PMA Record#
- Device
- FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
- Applicant
- Cook Medical Incorporated
- PMA number
- P100028
- Supplement
- S003
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2014-03-28
- Decision code
- APPR
- Date received
- 2013-01-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ADDITIONAL DELIVERY SYSTEM (FORMULA 535 DELIVERY SYSTEM) FOR THE FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM.