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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAMVISC AND AMVISC PLUS SODIUM HYALURONATE VISCOELASTICS
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantBAUSCH & LOMB, INC.
PMA NumberP810025
Supplement NumberS021
Date Received05/10/2002
Decision Date12/03/2002
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a buffered formulation (ph 6. 8 - 7. 6) for amvisc and amvisc plus sodium hyaluronate viscoelastics.
-
-