• 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 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.
 
DevicePOSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
BAUSCH & LOMB
1400 north goodman st.
rochester, NY 14609-3547
PMA NumberP870013
Supplement NumberS008
Date Received10/31/1995
Decision Date05/01/1996
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF THE FOLLOWING: IMPLEMENTATION OF NEW MANUFACTURING PROCESSES OF CLEAR AND VIOLET HAPTIC POLYMETHYLMETHACRYLATE (PMMA) ONE-PIECE POSTERIOR CHAMBER LENSES; THE USE OF A NEW TUMBLING PROCESS FOR YOUR THREE-PIECE LENSES; AND THE INTRODUCTION OF SEVERAL TIER A POSTERIOR CHAMBER LENSES, MODELS 8192, 8490B, 8492B, 8090B, 8091B, 8193B, 8491B, 8493B, 8990B, 8991B, 8093B, 8095B, 8195B, AND 8594B
-
-