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) | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePROVISC Ophthalmic Viscosurgical Device (latex-ftee packaging configuration)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAlcon Research, Ltd.
6201 SOUTH FREEWAY, R3-48
FORT WORTH, TX 76134-2099
PMA NumberP890047
Supplement NumberS048
Date Received07/21/2016
Decision Date10/31/2017
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a manufacturing site change located at Lifecore Biomedical, LLC., 3515 Lyman Boulevard, Chaska, Minnesota, USA, and Lifecore Biomedical, LLC, 1245 Lakeview Drive, Chaska, Minnesota, USA.
-
-