STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
FDA premarket approval P990071/S005 · decided 2005-06-06
Approval details
- PMA number
- P990071
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Applicant
- Biosense Webster, Inc.
- Date received
- 2003-12-22
- Decision date
- 2005-06-06
- Days to decision
- 532 days
- Decision code
- APPR
- Product code
- DRF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- 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.
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510(k) clearances by this applicant
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| CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) (K231412) | Biosense Webster, Inc. | 2023-07-10 |