• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 
Trade NameALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantALLERGAN PHARMACEUTICALS, INC.
PMA NumberN18020
Supplement NumberS040
Date Received05/30/1995
Decision Date09/20/1995
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a revised package insert text which is to be printed on the 8 fl. Oz and 15 fl. Oz. Aerosol cans of the referenced device and the elimination of the package insert for these size containers.
-
-