PMA P990071S005
- Device
- STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S005
- Product code
- DRF
- Decision date
- 2005-06-06
- Classification
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- APPROVAL FOR MANUAL OPERATION OF THE COOLFLOW IRRIGATION PUMP WITH THE BIOSENSE WEBSTER THERMOCOOL CATHETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COOLFLOW IRRIGATION PUMP. THE COOLFLOW IRRIGATION PUMP AND TUBING SET IS A PERISTALTIC IRRIGATION PUMP DESIGNED FOR THE DELIVERY OF SALINE SOLUTION WHEN USED IN CONJUNCTION WITH THE STOCKERT 70 RF GENERATOR AND THE THERMOCOOL IRRIGATION CATHETERS.
Current openFDA PMA Record#
- Device
- STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S005
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2005-06-06
- Decision code
- APPR
- Date received
- 2003-12-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MANUAL OPERATION OF THE COOLFLOW IRRIGATION PUMP WITH THE BIOSENSE WEBSTER THERMOCOOL CATHETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COOLFLOW IRRIGATION PUMP. THE COOLFLOW IRRIGATION PUMP AND TUBING SET IS A PERISTALTIC IRRIGATION PUMP DESIGNED FOR THE DELIVERY OF SALINE SOLUTION WHEN USED IN CONJUNCTION WITH THE STOCKERT 70 RF GENERATOR AND THE THERMOCOOL IRRIGATION CATHETERS.