WebSep 2, 2016 · Approved by the FDA, GalaFLEX is an absorbable polymer called P4HB. This naturally occurring polymer is woven together to make a mesh which provides internal support – like an underwire bra – to the …
GalaFLEX Surgical Scaffold RealSelf
WebGalaFLEX LITE scaffolds maintain greater than 50% strength at 90 days while supporting collagen deposition, organization, and strengthening tissue*. Rapidly absorbing scaffolds that degrade quickly may result in … WebSep 1, 2016 · GalaFLEX - GalaFLEX is the newest surgical mesh seen in breast augmentations and reconstruction. It is a naturally-occurring biopolymer knitted from P4HB (poly-4-hydroxybutyrate). GalaFLEX is a bit different in the fact that it is produced through a biologic fermentation process. There are other biopolymers used for medical purposes, … temptations vijayawada photos
AccessGUDID - DEVICE: GalaFLEX Scaffold (00855920006041)
WebNov 14, 2024 · To date I have 241 Strattice cases and 150 Galaflex/Galaform patients in my database that I have operated on and have breast implants so I have a pretty good experience and understanding of these products. I have used Strattice for longer as it was available before Galaflex and also had a pretty large series of Seri before I switched to … WebFORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2024 See PRA Statement below. 510(k) Number (if known) K161092 Device Name GalaSHAP … WebAccessGUDID - GalaFLEX Scaffold (00855920006010)- GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. P4HB bioresorbs through a process of hydrolysis and … temptations tempting tuna