FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
FDA premarket approval P100028/S001 · decided 2011-12-05
Approval details
- PMA number
- P100028
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
- Generic name
- STENT, RENAL
- Applicant
- Cook Medical Incorporated
- Date received
- 2011-10-06
- Decision date
- 2011-12-05
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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