PMA P980037S088

Device: AngioJet Rheolythic Thrombectomy Catheter System
Applicant: Boston Scientific Corp
PMA number: P980037
Supplement: S088
Product code: MCX
Decision date: 2022-05-06
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: Process devices using the reduced EtO S756 sterilization cycle at the BSC Coventry Rhode Island, BSC Galway Ireland, and Steris Tullamore Ireland facilities.

Current openFDA PMA Record#

Device: AngioJet Rheolythic Thrombectomy Catheter System
Applicant: Boston Scientific Corp
PMA number: P980037
Supplement: S088
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2022-05-06
Decision code: OK30
Date received: 2022-04-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Process devices using the reduced EtO S756 sterilization cycle at the BSC Coventry Rhode Island, BSC Galway Ireland, and Steris Tullamore Ireland facilities.