PMA P890017S005

Device: CORDIS PALMAZ(R) BALLOON-EXPANDABLE STENT
Applicant: Cordis US Corporation
PMA number: P890017
Supplement: S005
Product code: NIN
Decision date: 1998-09-25
Classification: Stent, Renal
Generic name: STENT, RENAL
Approval order 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.

Current openFDA PMA Record#

Device: CORDIS PALMAZ(R) BALLOON-EXPANDABLE STENT
Applicant: Cordis US Corporation
PMA number: P890017
Supplement: S005
Product code: NIN
Generic name: STENT, RENAL
Decision date: 1998-09-25
Decision code: OK30
Date received: 1998-09-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.