• 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 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.
 
DeviceARTISAN MYOPIA PHAKIC IOL
Classification Namelens, intraocular, phakic
Generic Namelens, intraocular, phakic
Applicant
OPHTEC BV
6421 congress ave,suite 112
boca raton, FL 33487
PMA NumberP030028
Supplement NumberS002
Date Received10/29/2010
Decision Date11/23/2010
Product Code
MTA[ Registered Establishments with MTA ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Shortening of ethylene oxide degassing phase process and the addition of an additional sterilization configuration.
-
-