PMA P980003S046
- Device
- CHILLI COOLED ABLATION CATHETER AND CABLE
- Applicant
- Boston Scientific Corp
- PMA number
- P980003
- Supplement
- S046
- Product code
- LPB
- Decision date
- 2014-02-13
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.
Current openFDA PMA Record#
- Device
- CHILLI COOLED ABLATION CATHETER AND CABLE
- Applicant
- Boston Scientific Corp
- PMA number
- P980003
- Supplement
- S046
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2014-02-13
- Decision code
- OK30
- Date received
- 2014-01-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.