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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceBOSTON EQUALENS (ITAFLUOROFOCON A) RIGID GAS PERMEABLE CONTACT LENS, EQUALENS 2 (OPRIFOCON A) RIGID GAS PERMEARABLE LENS
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Namelens,contact(rigid gas permeable)-extended wear
Regulation Number886.5916
Applicant
POLYMER TECHNOLOGY CORP.
1400 n. goodman st.
rochester, NY 14692
PMA NumberP860022
Supplement NumberS057
Date Received01/31/2008
Decision Date02/21/2008
Product Code
MWL[ Registered Establishments with MWL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for wet shipping, with storage up to 30 days, of the boston equalens, equalens ii and boston orthokeratology shaping rigid gas permeable contact lenses in boston simplus multi-action solution.
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