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.
 
DeviceBiomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantThe Cooper Companies
6150 Stoneridge Mall Rd.
Suite 370
Pleasanton, CA 94588
PMA NumberP890023
Supplement NumberS044
Date Received08/20/2020
Decision Date09/16/2020
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Implementation of a new sterilizer installed at the CooperVision Manufacturing facility in Juana Diaz, Puerto Rico.
-
-