• 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.
 
DeviceACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
7500 centurion pkwy.
jacksonville, FL 32256
PMA NumberN18033
Supplement NumberS030
Date Received05/02/1997
Decision Date05/14/1997
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to make a minor change in the initiator ratio (increased amount) for the acuvue(r) (etafilcon a) contact lens, which was approved as n18-033/s29 on october 7, 1996. The device, as modified, will be marketed under the current trade name with no change to the indications for use or the established shelf-life.
-
-