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.
 
DeviceINTACS PRESCRIPTION INSERTS
Generic NameImplant, corneal, refractive
ApplicantADDITION TECHNOLOGY
820 OAK CREEK DRIVE
LOMBARD, IL 60148
PMA NumberP980031
Supplement NumberS004
Date Received02/23/2000
Decision Date10/11/2001
Product Code LQE 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR 0.275 MM AND 0.325 MM INTACS(TM) AS WELL AS FOR A NEW TRADE NAME, "INTACS(TM) PRESCRIPTION INSERTS."
-
-