PMA P000020
- Device
- Bard Ablation System
- Applicant
- Boston Scientific Corp.
- PMA number
- P000020
- Supplement
- S017
- Decision date
- 2014-06-04
Current openFDA PMA Record
- Device
- BARD ABLATION SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P000020
- Supplement
- S017
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2014-06-04
- Decision code
- APPR
- Date received
- 2014-04-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR IMPLEMENTATION OF A CHANGE TO LEAD-FREE SOLDER IN THECONNECTOR COMPONENT OF THE STINGER AND SCORPION2 ABLATION CATHETERS.