PMA P860019S221

Device: PTCA CATHETERS
Applicant: Scimed Life Systems, Inc.
PMA number: P860019
Supplement: S221
Product code: LOX
Decision date: 2008-12-04
Classification: Catheters, Transluminal Coronary Angioplasty, Percutaneous
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR A CHANGE IN THE SAMPLING PERFORMED BY THE SUPPLIER FOR MEASURING THE COATING THICKNESS OF THE HYPOTUBE COMPONENT.

Current openFDA PMA Record#

Device: PTCA CATHETERS
Applicant: Scimed Life Systems, Inc.
PMA number: P860019
Supplement: S221
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 2008-12-04
Decision code: APPR
Date received: 2007-08-23
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN THE SAMPLING PERFORMED BY THE SUPPLIER FOR MEASURING THE COATING THICKNESS OF THE HYPOTUBE COMPONENT.