CORDIS PALMAZ(R) BALLOON-EXPANDABLE STENT
FDA premarket approval P890017/S005 · decided 1998-09-25
Approval details
- PMA number
- P890017
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CORDIS PALMAZ(R) BALLOON-EXPANDABLE STENT
- Generic name
- STENT, RENAL
- Applicant
- Cordis US Corporation
- Date received
- 1998-09-02
- Decision date
- 1998-09-25
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- The 30-day notice requested that FDA review a change involving the transfer of an intermediate manufacturing process. The electropolishing of the metal stent and post-polishing stent inspection operation will be transferred from Corids Corporation to one of the suppliers, Norman Noble, Inc. of Cleveland, Ohio.
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