PMA P010068S002
- Device
- QWIKSTAR DS DIAGNOSTIC/ABLATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S002
- Product code
- OAD
- Decision date
- 2004-01-14
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- APPROVAL FOR MODIFICATIONS MAD TO THE NAVISTAR DS 8MM TIP DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER APPROVED UNDER P010068 AND THE QWIKSTAR 4 MM DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER APPROVED UNDER P990025/S004. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QWIKSTAR DS DIAGNOSTIC/ABLATION CATHETER AND IS INDICATED FOR CATHETER BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING) AND WHEN USED WITH THE STOCKERT 70 RF GENERATOR (SOFTWARE VERSION 1.033 OR HIGHER) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS 18 YEARS OR OLDER.
Current openFDA PMA Record#
- Device
- QWIKSTAR DS DIAGNOSTIC/ABLATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S002
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2004-01-14
- Decision code
- APPR
- Date received
- 2003-11-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS MAD TO THE NAVISTAR DS 8MM TIP DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER APPROVED UNDER P010068 AND THE QWIKSTAR 4 MM DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER APPROVED UNDER P990025/S004. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QWIKSTAR DS DIAGNOSTIC/ABLATION CATHETER AND IS INDICATED FOR CATHETER BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING) AND WHEN USED WITH THE STOCKERT 70 RF GENERATOR (SOFTWARE VERSION 1.033 OR HIGHER) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS 18 YEARS OR OLDER.