News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Paragon BioTeck Grabs FDA Approval For Comfortear Lacrisolve Absorbable Punctum Plug



6/25/2014 4:44:23 PM

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

Paragon BioTeck, Inc. Receives FDA Clearance for Comfortear Lacrisolve Absorbable Punctum Plug

PORTLAND, Ore., June 25, 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 it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Comfortear® Lacrisolve Absorbable Punctum Plug.

"Receiving FDA 510(k) clearance for this device is an important milestone for Paragon. Dry eye affects over 4.8 million people in the U.S. and, 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 FDA regulated ophthalmic products," says 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://www.paragonbioteck.com/.

Product Availability:
The Comfortear® Lacrisolve Absorbable Punctum Plugs will ship July 2014. To preorder or learn more about Paragon's products, call 888-424-1192. Product orders or inquiries can also be sent to orders@paragonbioteck.com.

For up to date information on Paragon BioTeck, Inc., subscribe to its newsletter to receive important information regarding the product launch, special offers and more.

About Paragon BioTeck, Inc.:
Paragon BioTeck 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, please visit http://www.paragonbioteck.com/ or call 888-424-1192; or email info@paragonbioteck.com.

*PHOTO: Send2Press.com/mediaboom/14-0625-comfortear_300dpi.jpg

*Photo Caption: Comfortear® Lacrisolve Absorbable Punctum Plugs.

This release was issued through Send2Press(R), a unit of Neotrope(R). For more information, visit Send2Press Press Release Distribution at http://www.Send2Press.com

SOURCE Paragon BioTeck, Inc.

Help employers find you! Check out all the jobs and post your resume.

Read at BioSpace.com


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES