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.
 
DevicePreVue Pre-Loaded System
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantHOYA SURGICAL OPTICS, INC.
14768 PIPELINE AVENUE
CHINO HILLS, CA 91709
PMA NumberP080004
Supplement NumberS042
Date Received09/02/2021
Decision Date02/28/2022
Product Code HQL 
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 located at HOYA Lamphun Ltd., 75/2 Moo 4, Tambol Banklang, Amphur Muang, Lamphun 51000, Thailand. Specifically, the approval is for machining, polishing, inspection, assembly, and primary packaging (pre-sterilization) of raw material buttons.
-
-