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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameEP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency generator/cardiac ablation catheter
ApplicantBOSTON SCIENTIFIC
PMA NumberP020025
Date Received06/24/2002
Decision Date08/25/2003
Product Code
OAD[ Registered Establishments with OAD ]
Docket Number 03M-0427
Notice Date 09/17/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the ep technologies ept-1000 xp rf ablation system. The blazer ii xp cardiac ablation catheter is indicated for use with the ept-1000 xp cardiac ablation controller and accessories for the treatment of sustained or recurrent type i atrial flutter in patients age 18 or older. The ept-1000 xp cardiac ablation controller and accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S015 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S042 S043 S044 S045 S046 S047 S048 
S049 S050 S051 S052 S053 S054 S055 
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