PMA P010068S031

Device: UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX S)
Applicant: Biosense Webster, Inc.
PMA number: P010068
Supplement: S031
Product code: OAD
Decision date: 2013-06-06
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: APPROVAL FOR MODIFIED CATHETER DESIGNS TO THE 7FR CELSIUS AND 7FR EZ STEER DS CATHETERS TO CREATE THE 7.5FR 8 MM CELSIUS FLTR CATHETERS. THE CHANGES BEING APPROVED ARE THE INCREASED DISTAL PROFILE, LARGER CURVE PROFILE, INCREASED RANGE OF DEFLECTION, AND INCREASED DEFLECTABLE TIP DIAMETER. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S) AND UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX-S) AND ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING), AND WHEN USED WITH THE STOCKERT 70 (WITH SOFTWARE VERSION 001/033 OR HIGHER) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 YEARS OF AGE OR OLDER.

Current openFDA PMA Record#

Device: UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX S)
Applicant: Biosense Webster, Inc.
PMA number: P010068
Supplement: S031
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2013-06-06
Decision code: APPR
Date received: 2012-11-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFIED CATHETER DESIGNS TO THE 7FR CELSIUS AND 7FR EZ STEER DS CATHETERS TO CREATE THE 7.5FR 8 MM CELSIUS FLTR CATHETERS. THE CHANGES BEING APPROVED ARE THE INCREASED DISTAL PROFILE, LARGER CURVE PROFILE, INCREASED RANGE OF DEFLECTION, AND INCREASED DEFLECTABLE TIP DIAMETER. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S) AND UNI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1355-XX-S) AND ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING), AND WHEN USED WITH THE STOCKERT 70 (WITH SOFTWARE VERSION 001/033 OR HIGHER) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 YEARS OF AGE OR OLDER.