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 ELASTIMIDE(TM) MODELS AQ-1016VL, AQ-2003VL, AQ-2010VL POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantSTAAR SURGICAL CO.
1911 WALKER AVE.
MONROVIA, CA 91016
PMA NumberP880091
Supplement NumberS008
Date Received04/18/1996
Decision Date10/17/1996
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 TIER A MODELS A1-1016VL, AQ-2003VL, AND AQ-2010VL
-
-