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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
Generic NameCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Regulation Number870.1220
ApplicantBiosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP990071
Supplement NumberS002
Date Received11/29/2001
Decision Date02/15/2002
Product Code DRF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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