Product code PSQ

Device name

Intracardiac Patch Or Pledget, Biologically Derived

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.3470

Review panel

CV

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.

Source

FDA openFDA device classification dataset