CORDIS PALMAZ BALLOON-EXPANDABLE STENT FOR THE ILIAC AND RENAL ARTERIES
FDA premarket approval P890017/S014 · decided 2006-04-21
Approval details
- PMA number
- P890017
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CORDIS PALMAZ BALLOON-EXPANDABLE STENT FOR THE ILIAC AND RENAL ARTERIES
- Generic name
- STENT, RENAL
- Applicant
- Cordis US Corporation
- Date received
- 2006-01-20
- Decision date
- 2006-04-21
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL TO CHANGE THE BACTERIAL ENDOTOXIN TEST METHOD TO THE KINETIC CHROMOGENIC LAL TEST METHOD, PER 2005 USP 28, NF23, CHAPTER <85>.
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