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.
 
DeviceBOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantBAUSCH & LOMB
1400 N. GOODMAN ST.
ROCHESTER, NY 14692
PMA NumberP860022
Supplement NumberS052
Date Received01/05/2000
Decision Date02/04/2000
Product Code HQD 
Advisory Committee Ophthalmic
Supplement Type 30-Day Supplement
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval under a 30-day notice for addition of one finishing laboratory, Procornea Nederland BV, Kollergan9, NL-6961 LZ Eerbeek, The Netherlands, to become an additional manufacturing and distributino site for the referenced devices.
-
-