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U.S. Department of Health and Human Services

Product Classification

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Device aortic annuloplasty ring
Regulation Description Annuloplasty ring.
Definition To correct annular dilatation and/or maintain annular geometry of the aortic valve.
Physical State A three dimensional crown or waveform shaped ring.
Technical Method A solid or compliant ring attached to the aortic annulus.
Target Area Aortic valve.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePST
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Structural Heart Devices Branch (SHDB)
Submission Type 510(k)
Regulation Number 870.3800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible