PMA P030031S146

Device: EZ STEER THERMOCOOL NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHE
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S146
Product code: OAD
Decision date: 2026-09-15
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: an additional supplier for critical components

Current openFDA PMA Record#

Device: EZ STEER THERMOCOOL NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHE
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S146
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2026-09-15
Decision code: OK30
Date received: 2026-08-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an additional supplier for critical components