PMA P210027S019

Device: QDOT MICRO BI-DIRECTIONAL NAVIGATION CATHETER; QDOT MICRO UNI-DIRECTIONAL NAVIGATION CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P210027
Supplement: S019
Product code: OAE
Decision date: 2026-09-15
Classification: Cardiovascular
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: an additional supplier for critical components

Current openFDA PMA Record#

Device: QDOT MICRO BI-DIRECTIONAL NAVIGATION CATHETER; QDOT MICRO UNI-DIRECTIONAL NAVIGATION CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P210027
Supplement: S019
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
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