• 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.
 
DeviceMENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Classification Namelens, contact (other material) - daily
Generic Namelens, contact (other material) - daily
Regulation Number886.5916
Applicant
MENICON CO. LTD.
269a ballardvale st.
wilmington, MA 01887
PMA NumberP880098
Supplement NumberS012
Date Received11/19/2002
Decision Date12/10/2002
Product Code
HQD[ Registered Establishments with HQD ]
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 for alcon unique-ph multi-purpose solution as an alternate wet shipping solution for the menicon sf-p rigid gas permeable contact lens, labeling changes to reflect the use of alcon unique-ph as a packaging solution and to update the labeling in accordance with recently approved menicon rigid gas permeable contact lens labeling.
-
-