• 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 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.
 
DeviceBIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
FERRING PHARMACEUTICALS, INC.
100 interpace parkway
parsippany, NJ 07054
PMA NumberP960011
Supplement NumberS009
Date Received07/09/2004
Decision Date01/27/2005
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in manufacturing site to the bio-technology general, ltd. Facility in be'er tuvia, israel, and for a change in the specifications for the active pharmaceutical product in biolon.
-
-