PMA P990071S046

Device: Stockert SMARTABLATE System
Applicant: Biosense Webster, Inc.
Product code: LPB
Decision date: 2021-09-23
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: Approval for a new manufacturing site located at STOCKERT GMBH, Boetzinger Strasse 31, Freiburg, Baden-Wurttemberg, Germany D-79111 for the manufacturing of the SMARTABLATE® System (which consists of the SMARTABLATE® Radiofrequency (RF) Generator, SMARTABLATE® Remote Control, SMARTABLATE® Irrigation Pump).

Current openFDA PMA Record#

Device: Stockert SMARTABLATE System
Applicant: Biosense Webster, Inc.
PMA number: P990071
Supplement: S046
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2021-09-23
Decision code: APPR
Date received: 2020-10-27
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a new manufacturing site located at STOCKERT GMBH, Boetzinger Strasse 31, Freiburg, Baden-Wurttemberg, Germany D-79111 for the manufacturing of the SMARTABLATE® System (which consists of the SMARTABLATE® Radiofrequency (RF) Generator, SMARTABLATE® Remote Control, SMARTABLATE® Irrigation Pump).