PMA P100028S001
- Device
- FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
- Applicant
- Cook Medical Incorporated
- PMA number
- P100028
- Supplement
- S001
- Product code
- NIN
- Decision date
- 2011-12-05
- Generic name
- STENT, RENAL
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
- Applicant
- Cook Medical Incorporated
- PMA number
- P100028
- Supplement
- S001
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2011-12-05
- Decision code
- APPR
- Date received
- 2011-10-06
- 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.