• 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 | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceKAMRA INLAY
Generic Nameimplant, corneal, refractive
ApplicantCorneaGen
1200 6th avenue
suite 300
seattle, WA 98101
PMA NumberP120023
Date Received12/12/2012
Decision Date04/17/2015
Withdrawal Date 02/03/2022
Product Code LQE 
Docket Number 15M-1326
Notice Date 04/29/2015
Advisory Committee Ophthalmic
Clinical TrialsNCT00819299
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE KAMRA INLAY. THE KAMRA INLAY IS INDICATED FOR INTRASTROMAL CORNEAL IMPLANTATION TO IMPROVE NEAR VISION BY EXTENDING THE DEPTH OF FOCUS IN THE NON-DOMINANT EYE OF PHAKIC, PRESBYOPIC PATIENTS BETWEEN THE AGES OF 45 AND 60 YEARS OLD WHO HAVE CYCLOPLEGIC REFRACTIVE SPHERICAL EQUIVALENT OF +0.50 D TO -0.75 D WITH LESS THAN OR EQUAL TO 0.75 D OF REFRACTIVECYLINDER, WHO DO NOT REQUIRE GLASSES OR CONTACT LENSES FOR CLEAR DISTANCE VISION, AND WHO REQUIRE NEAR CORRECTION OF +1.00 D TO +2.50 D OF READING ADD.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S004 S005 
-
-