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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.
 
DeviceFLEXABILITY ABLATION CATHETER
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantAbbott Medical
2375 MORSE AVENUE
Plymouth, MN 55442
PMA NumberP110016
Supplement NumberS013
Date Received06/19/2014
Decision Date01/23/2015
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FLEXABILITY ABLATION CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLEXABILITY ABLATION CATHETERAND IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMP AND A COMPATIBLE RF CARDIACABLATION GENERATOR. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIACABLATION PROCEDURES (MAPPING STIMULATION, AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.
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