• 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.
 
DevicePOSTERIOR CHAMBER INTRAOCULAR LENSES
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
AAREN SCIENTIFIC
4290 east brickell st, bldg a
ontario, CA 91761
PMA NumberP970034
Supplement NumberS004
Date Received02/14/2000
Decision Date04/28/2000
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for Allergan Surgical to distribute the Models RS-50B, RS-55B, RS-60B, RS-65, SP-60A, and SP-65A2 ultraviolet-absorbing posterior chamber intraocular lenses as Allergan's Duralens Models 52, 53, 54, 59, 60, and 65T, respectively.
-
-