PMA P980003S085

Device: Chilli II Cooled Ablation Catheter and Cable
Applicant: Boston Scientific Corp
PMA number: P980003
Supplement: S085
Product code: LPB
Decision date: 2018-09-07
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: Approval for updating the optimized BSC2000-2 cycle conducted in Chamber 7 at the BSC Coventry, RI facility with new Programmable Logic Controller (PLC) software.

Current openFDA PMA Record#

Device: Chilli II Cooled Ablation Catheter and Cable
Applicant: Boston Scientific Corp
PMA number: P980003
Supplement: S085
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2018-09-07
Decision code: APPR
Date received: 2018-04-06
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for updating the optimized BSC2000-2 cycle conducted in Chamber 7 at the BSC Coventry, RI facility with new Programmable Logic Controller (PLC) software.