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U.S. Department of Health and Human Services

Product Classification
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Device stent delivery system
Definition For coarctation of the aorta
Physical State For coarctation of the aorta
Technical Method For coarctation of the aorta
Target Area Aorta
Review Panel Cardiovascular
Product CodePKK
Premarket Review Office of Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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