Decellularized Bovine Pericardium
PhotoFix Decellularized Bovine Pericardium - PFP1X6
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.
- Do not place the pericardium in areas where significant temperature fluctuations occur.
- Width: 1 Centimeter
- Length: 6 Centimeter
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
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: CVDevice Identifiers
Device Id: 00877234000539
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