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) | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceUV ABSORBING POSTERIOR CHAMBER IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantALCON LABORATORIES
6201 S FREEWAY
FT WORTH, TX 76134
PMA NumberP810018
Supplement NumberS035
Date Received08/09/1995
Decision Date12/13/1995
Withdrawal Date 12/20/2002
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS INCLUDING AERATION TIME AND THE ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME
-
-