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.
 
DeviceULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES,MODEL C11UB
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547
PMA NumberP910058
Supplement NumberS011
Date Received01/12/2000
Decision Date04/18/2000
Withdrawal Date 09/17/2010
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an alternate packaging configuration comprising a different lens carrier design and a single, rather than double, autoclavable pouch.
-
-