PMA P040016

Device: VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM
Applicant: Boston Scientific Scimed, Inc.
PMA number: P040016
Supplement: S134
Product code: MAF
Decision date: 2015-08-12
Generic name: STENT, CORONARY
Approval order statement: APPROVAL FOR REMOVAL OF THE STENT MASS IN-PROCESS MEASUREMENT AND AN ALTERNATE SAMPLING PLAN FOR THE WALL THICKNESS IN-PROCESS MEASUREMENT.

Current openFDA PMA Record#

Device: VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM
Applicant: Boston Scientific Scimed, Inc.
PMA number: P040016
Supplement: S134
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2015-08-12
Decision code: APPR
Date received: 2014-11-14
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR REMOVAL OF THE STENT MASS IN-PROCESS MEASUREMENT AND AN ALTERNATE SAMPLING PLAN FOR THE WALL THICKNESS IN-PROCESS MEASUREMENT.