Decellularized Bovine Pericardium

Decellularized Bovine Pericardium
PhotoFix Decellularized Bovine Pericardium - PFP8X14

An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.

• Width: 8 Centimeter
• Length: 14 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PSQ

Device Name: Intracardiac Patch Or Pledget, Biologically Derived

Device Class: 2

Physical State: The device is a biologic tissue, typically in the form of a sheet. The tissue may be decellularized or crosslinked, and may be derived from human or animal sources.

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

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device is sutured into the intended site to repair or support the native tissue.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Heart and vasculature

Regulation Number: 870.3470

Third Party Flag: N

Medical Specialty: CV

Device Id: 00877234000560

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A