PORTLAND, Ore., Nov. 17, 2014 (SEND2PRESS NEWSWIRE) — 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 for media: Send2Press.com/wire/images/14-1016-Lacrisolve-300dpi.jpg .
*Caption: Comfortear® Lacrisolve™ Absorbable Punctum Plugs.
News issued by: Paragon BioTeck, Inc.
Original Image: https://www.send2press.com/wire/images/14-1016-Lacrisolve-500×375.jpg
# # #
Original Story ID: 2014-11-1117-003 (9787) :: paragon-bioteck-receives-ce-mark-approval-on-comfortear-lacrisolve-absorbable-punctum-plug-2014-11-1117-003
Original Keywords: FDA 510(k) clearance, CE mark, ophthalmic products, biopharmaceutical and medical device company Paragon BioTeck, Inc. Portland Oregon PORTLAND, Ore.
Alternate Headline: Pphthalmic Pharmaceuticals Company Paragon BioTeck Receives CE Mark Approval on Comfortear Lacrisolve Absorbable Punctum Plug
NEWS ARCHIVE NOTE: this archival news content, issued by the news source via Send2Press Newswire, was originally located in the Send2Press® 2004-2015 2.0 news platform and has been permanently converted/moved (and redirected) into our 3.0 platform. Also note the story “reads” counter (bottom of page) does not include any data prior to Oct. 30, 2016. This press release was originally published/issued: Mon, 17 Nov 2014 08:00:00 +0000
Original Shortcode for Story: http://i.send2press.com/IifoF
News Source: Paragon BioTeck Inc.
