• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePARAGON CRT, PARAGON CRT 100, PARAGON RG-4 RIGID GAS PERMABLE CONTACT LENS
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Nameextended wear, rigid gas permeable, contact lens
Regulation Number886.5916
ApplicantPARAGON VISION SCIENCES
PMA NumberP870024
Supplement NumberS049
Date Received10/25/2010
Decision Date07/28/2014
Product Code
MWL[ Registered Establishments with MWL ]
Advisory Committee Ophthalmic
Clinical Trials NCT01272271
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling update to the package insert and patient information booklet to include the results from a section 522 postmarket surveillance study (pas).
-
-