PMA P900056S156

Device: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S156
Product code: MCX
Decision date: 2016-12-19
Classification: Catheter, Coronary, Atherectomy
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: Transfer manufacturing for the RotaWire Extra Support Core Wires component from the approved vendor, Lake Region Medical Arvada, to Lake Region Medical Galway.

Current openFDA PMA Record#

Device: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S156
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2016-12-19
Decision code: OK30
Date received: 2016-12-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Transfer manufacturing for the RotaWire Extra Support Core Wires component from the approved vendor, Lake Region Medical Arvada, to Lake Region Medical Galway.