PMA P000020S018

Current openFDA PMA Record

Device: BARD ABLATION SYSTEM
Applicant: Boston Scientific Corp
PMA number: P000020
Supplement: S018
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2014-05-16
Decision code: OK30
Date received: 2014-04-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ACCEPTANCE TO IMPLEMENT AN ADDITIONAL SUPPLIER TO PERFORM MACHINING OF THE ABLATION CATHETER HANDLE COMPONENTS.