FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
FDA premarket approval P100028/S003 · decided 2014-03-28
Approval details
- PMA number
- P100028
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
- Generic name
- STENT, RENAL
- Applicant
- Cook Medical Incorporated
- Date received
- 2013-01-28
- Decision date
- 2014-03-28
- Days to decision
- 424 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR AN ADDITIONAL DELIVERY SYSTEM (FORMULA 535 DELIVERY SYSTEM) FOR THE FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM.
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