STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION
FDA premarket approval P990071/S007 · decided 2005-07-12
Approval details
- PMA number
- P990071
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Biosense Webster, Inc.
- Date received
- 2005-04-11
- Decision date
- 2005-07-12
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR REPLACING SOFTWARE VERSION 1.034B WITH VERSION 1.035. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STOCKERT 70 RF GENERATOR FOR CARDIAC ABLATION AND IS INDICATED FOR USE IN CONJUNCTION WITH A COMPATIBLE CATHETER FOR CARDIAC ABLATION PROCEDURES.
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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 |