PMA P900056S160

Device: Rotablator® Rotational Atherectomy System
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S160
Product code: MCX
Decision date: 2017-05-12
Classification: Catheter, Coronary, Atherectomy
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: Sterilization of devices within the scope of this bundled submission with the optimized BSC2000-2 cycle in Chamber 3 at the Synergy Health/Steris, Costa Rica facility.

Current openFDA PMA Record#

Device: Rotablator® Rotational Atherectomy System
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S160
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2017-05-12
Decision code: OK30
Date received: 2017-04-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Sterilization of devices within the scope of this bundled submission with the optimized BSC2000-2 cycle in Chamber 3 at the Synergy Health/Steris, Costa Rica facility.