PMA P990071S017

Device
STOCKERT 70 RADIOFREQUENCY GENERATOR
Applicant
Biosense Webster, Inc.
PMA number
P990071
Supplement
S017
Product code
LPB
Decision date
2013-03-07
Classification
Cardiac Ablation Percutaneous Catheter
Generic name
Cardiac ablation percutaneous catheter
Approval order statement
APPROVAL OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM.

Current openFDA PMA Record#

Device
STOCKERT 70 RADIOFREQUENCY GENERATOR
Applicant
Biosense Webster, Inc.
PMA number
P990071
Supplement
S017
Product code
LPB
Generic name
Cardiac ablation percutaneous catheter
Decision date
2013-03-07
Decision code
APPR
Date received
2012-04-16
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM.