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Device | STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990071 |
Date Received | 11/09/1999 |
Decision Date | 05/31/2000 |
Product Code |
LPB |
Docket Number | 03M-0045 |
Notice Date | 03/01/2003 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement THE STOCKERT 70 RF GENERATOR SYSTEM IS INDICATED FOR USE WITH A BIOSENSE WEBSTER DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER TO DELIVER RF ENERGY DURING CARDIAC ABLATION PROCEDURES. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S015 S016 S017 S018 S019 S020 S022 S023 S024 S025 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 |