PMA P990071S027

Device: SMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM FOR CARDIAC ABLATION)
Applicant: Biosense Webster, Inc.
PMA number: P990071
Supplement: S027
Product code: LPB
Decision date: 2014-07-02
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: APPROVAL FOR HARDWARE MODIFICATIONS TO THE SMARTABLATE IRRIGATION PUMP THAT UPDATE THE HARDWARE FROM VERSION 1 TO VERSION 2.

Current openFDA PMA Record#

Device: SMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM FOR CARDIAC ABLATION)
Applicant: Biosense Webster, Inc.
PMA number: P990071
Supplement: S027
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2014-07-02
Decision code: APPR
Date received: 2014-04-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR HARDWARE MODIFICATIONS TO THE SMARTABLATE IRRIGATION PUMP THAT UPDATE THE HARDWARE FROM VERSION 1 TO VERSION 2.