• 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
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 NamePROVISC OPHTHALMIC VISCOSURGICAL DEVICE
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP890047
Supplement NumberS042
Date Received08/16/2013
Decision Date11/13/2013
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to discontinue the current intravitreal test and replace it with the inflammatory release assay for the provisc ibc ophthalmic viscosurgical device.
-
-