WebBrand Name: PhotoFix Decellularized Bovine Pericardium Version or Model: PFP0.8X8 Commercial Distribution Status: In Commercial Distribution Catalog Number: PFP0.8X8 Company Name: Cryolife, Inc. Primary DI Number: ... Cardiovascular patch, animal-derived An implantable material designed to reinforce suture lines and/or increase the strength of ... Webpatch, pledget and intracardiac, petp, ptfe, polypropylene: 510(k) Number: K162506: Device Name: PhotoFix Decellularized Bovine Pericardium: Applicant
Retrospective Evaluation of Photo-oxidized Decellularized …
WebDec 31, 2024 · PhotoFix is a bovine pericardial patch fixated using a dye-mediated photo-oxidation process without the use of glutaraldehyde. We hold FDA 510(k) clearance and a CE Mark for PhotoFix which is indicated for use in intracardiac repair, great vessel repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for ... WebTop local news. If It’s On The Curb Or Stoop, It's Yours — Mostly: [Block Talk] “It’s the greatest thing ever,” one reader says of “curb mining.”. Others concur, but point out a ... the us department of justice oversees
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WebThere have been a series of cases at (b)(6) hospital (b)(6) where the fda approved product (under the 510k clearance pathway): photofix decellularized bovine pericardium (intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene) has been noted to have important loss in integrity to the point of … WebAug 7, 2014 · Steven G. Anderson, chairman, president, and CEO of CryoLife, said, "We believe that Genesee's PhotoFix bovine pericardial patch has the potential to become the product of choice for pediatric ... WebCommercially Available Surgical Implants. Surgical materials tested included Cardiocel acellular collagen scaffold (LeMaitre Vascular, Burlington, Mass), Photofix decellularized bovine pericardium (Cryolife, Kennesaw, Ga), first- and second-generation Cor PATCH acellular porcine small intestinal submucosa (CorMatrix Cardiovascular Inc, Sunnyvale, … the us digital policyschaffer washingtonpost