• 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 NameCRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS (IOL)
Classification Namelens,intraocular,accommodative
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP030002
Supplement NumberS019
Date Received05/01/2009
Decision Date06/30/2009
Product Code
NAA[ Registered Establishments with NAA ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the physician¿s labeling to include the addition of 0. 25 diopter increments for the crystalens model hd500 and hd520 as follows: the addition of 0. 25 diopter increments for model hd500 lenses in the +18 to +22 dioptric power range and for model hd520 lenses in the +16. 25 to +16. 75 dioptric power range.
-
-