• 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 NameADATO SIL-OL 5000 SILICONE OIL SYRINGE
Classification Namefluid, intraocular
Generic Namesilicone oil
Regulation Number886.4275
ApplicantBAUSCH & LOMB, INC.
PMA NumberP910071
Supplement NumberS006
Date Received01/29/2002
Decision Date12/23/2002
Product Code
LWL[ Registered Establishments with LWL ]
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 for the following changes for adato sil-ol 5000 silicone oil: 1) addition of a new primary container closure system (glass syringe); 2) pharm pur gmbh, augsburg, germany, as the site for filling, sterilization, labeling and packaging for adato sil-ol 5000 silicone oil packaged in a syringe; 3) parametric release of the adato sil-ol 5000 silicone oil syringe packaged product in lieu of end product sterility testing; and 4) double pouch packaging for adato sil-ol 5000 silicone oil syringe.
-
-