PMA P980003S091

Device: Chilli II Cooled Ablation Catheter and Cable
Applicant: Boston Scientific Corp
PMA number: P980003
Supplement: S091
Product code: LPB
Decision date: 2019-11-07
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: Reduce the Ethylene Oxide gas concentration and qualify additional process challenge devices used in the BSC2000-2 sterilization cycle.

Current openFDA PMA Record#

Device: Chilli II Cooled Ablation Catheter and Cable
Applicant: Boston Scientific Corp
PMA number: P980003
Supplement: S091
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2019-11-07
Decision code: OK30
Date received: 2019-10-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Reduce the Ethylene Oxide gas concentration and qualify additional process challenge devices used in the BSC2000-2 sterilization cycle.