DYE

Replacement Heart-Valve

Product code
DYE
Device name
Replacement Heart-Valve
Device class
Class 3
21 CFR
21 CFR 870.3925
Medical specialty
Cardiovascular
Marketing pathway
PMA
Flag
Implant

FDA classification definition

Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: DYE
Classification and pathway per current FDA publications. Data from openFDA (CC0).