PMA P950020S068

Device: FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE
Applicant: Boston Scientific Corp
PMA number: P950020
Supplement: S068
Product code: MAF
Decision date: 2014-08-29
Classification: Stent, Coronary
Generic name: STENT, CORONARY
Approval order statement: CHANGE TO MOVE THE ELECTRICAL DISCHARGE MACHINING (EDM) PROCESS FOR A COMPONENT OF THE BSC FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE TO THE BSC MAPLE GROVE, MINNESOTA FACILITY.

Current openFDA PMA Record#

Device: FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE
Applicant: Boston Scientific Corp
PMA number: P950020
Supplement: S068
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2014-08-29
Decision code: OK30
Date received: 2014-07-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO MOVE THE ELECTRICAL DISCHARGE MACHINING (EDM) PROCESS FOR A COMPONENT OF THE BSC FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE TO THE BSC MAPLE GROVE, MINNESOTA FACILITY.