FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
FDA premarket approval P100028/S004 · decided 2014-10-08
Approval details
- PMA number
- P100028
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
- Generic name
- STENT, RENAL
- Applicant
- Cook Medical Incorporated
- Date received
- 2013-09-20
- Decision date
- 2014-10-08
- Days to decision
- 383 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR A LABELING UPDATE BASED ON THE POST-APPROVAL STUDY RESULTS.
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