PMA P010068S074

Device
Interface Cable for Multi-Electrode Ablation Catheters (nMARQ)
Applicant
Biosense Webster, Inc.
PMA number
P010068
Supplement
S074
Product code
OAD
Decision date
2025-02-26
Classification
Cardiovascular
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement
Sterilization Chamber Addition and Processing Specification Change for production of cables

Current openFDA PMA Record#

Device
Interface Cable for Multi-Electrode Ablation Catheters (nMARQ)
Applicant
Biosense Webster, Inc.
PMA number
P010068
Supplement
S074
Product code
OAD
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date
2025-02-26
Decision code
OK30
Date received
2024-12-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Sterilization Chamber Addition and Processing Specification Change for production of cables