Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameIMPLANTABLE COLLAMER LENS (VISIAN ICL)
Classification Namelens, intraocular, phakic
Generic Namephakic intraocular lens for myopic correction
ApplicantSTAAR SURGICAL CO.
PMA NumberP030016
Supplement NumberS023
Date Received02/29/2012
Decision Date06/08/2012
Product Code
MTA[ Registered Establishments with MTA ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
-
-