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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSTOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Nameradiofrequency generator and accessories/accessory cable
Regulation Number870.1220
ApplicantBIOSENSE WEBSTER, INC.
PMA NumberP990071
Supplement NumberS002
Date Received11/29/2001
Decision Date02/15/2002
Product Code
DRF[ Registered Establishments with DRF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) adapter cables (models d-1170-27-001, d-1170-28-001, and d-1170-29-001) that connect the stockert 70 rf generator cable to compatible catheters and 2) a new indications for use for the stockert 70 rf generator. The adapter cables will be marketed under the trade name stockert 70 rf generator cable adapters for cardiac ablation. Both the stockert 70 rf generator cable adapters for cardiac ablation and stockert 70 rf generator are indicated for use in conjunction with a compatible catheter for cardiac ablation procedures.
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