PORTLAND, Ore., Nov. 17, 2014 /PRNewswire/ -- Paragon BioTeck, Inc., a privately held biopharmaceutical and medical device company specializing in the development of ophthalmic pharmaceuticals, devices and therapies, announced today that it has received CE mark approval for the recently FDA cleared Comfortear® Lacrisolve Absorbable Punctum Plug. CE mark approval is recognized and associated with safety and performance in multiple countries.
“Receiving FDA 510(k) clearance for this device was an important milestone for Paragon. Now receiving the CE mark approval will allow additional commercialization throughout the European Union. In keeping with Paragon’s ultimate goal to protect and preserve eyesight, the Comfortear® Lacrisolve Absorbable Punctum Plug is a great addition to our portfolio of ophthalmic products,” said Lauren M-C Bluett, Director of Quality Assurance.
About Comfortear® Lacrisolve Absorbable Punctum Plug:
Comprised of the synthetic absorbable polymer, polydioxanone, the Comfortear® Lacrisolve Absorbable Punctum Plugs are medium-term implants designed to be inserted into the canaliculus in order to block tear drainage through the lacrimal drainage system. The Comfortear® Lacrisolve Absorbable Punctum Plugs are available in two diameters: 0.4mm and 0.5mm. The implants are supplied sterile with two implants per package.
Absorption time for the Comfortear® Lacrisolve Absorbable Punctum Plugs is approximately 6 months (=<6). For full prescribing information, visit http://paragonbioteck.com/products/.
About Paragon BioTeck, Inc.:
Paragon BioTeck, Inc. is a privately held ophthalmic-focused biopharmaceutical and medical device company pursuing the development and commercialization of products addressing unmet medical needs in the fight to protect and preserve eyesight. For more information on the company and its work, visit http://www.paragonbioteck.com.
For more information please call 888-424-1192 or email to info@paragonbioteck.com.
*PHOTO: Send2Press.com/mediaboom/14-1016-Lacrisolve-300dpi.jpg .
*Caption: Comfortear(R) Lacrisolve(TM) Absorbable Punctum Plugs.
This release was issued through Send2Press(R), a unit of Neotrope(R). For more information, visit Send2Press Newswire at https://www.Send2Press.com
SOURCE Paragon BioTeck, Inc.
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