FORMULA BALLOOL-EXPANDABLE RENAL STENT SYSTEM
FDA premarket approval P100028/S002 · decided 2012-04-30
Approval details
- PMA number
- P100028
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FORMULA BALLOOL-EXPANDABLE RENAL STENT SYSTEM
- Generic name
- STENT, RENAL
- Applicant
- Cook Medical Incorporated
- Date received
- 2012-02-13
- Decision date
- 2012-04-30
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR THE 4 MM VERSION OF THE STENT TO BE USED WITH THE FORMULA 414 RX DELIVERY SYSTEM.
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