PMA P030031S137

Device: NAVISTAR RMT Thermocool Electrophysiology Catheter, EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, T
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S137
Product code: OAD
Decision date: 2024-11-20
Classification: Cardiovascular
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: an additional supplier for electromagnetic interference (EMI) shield components

Current openFDA PMA Record#

Device: NAVISTAR RMT Thermocool Electrophysiology Catheter, EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, T
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S137
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2024-11-20
Decision code: OK30
Date received: 2024-10-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an additional supplier for electromagnetic interference (EMI) shield components