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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 II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR EXTENDED WEAR
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 NumberS055
Date Received10/28/2003
Decision Date11/25/2003
Product Code
MWL[ Registered Establishments with MWL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for combining the daily wear and extended wear labeling of the device to bring the extended wear labeling into alignment with the daily wear labeling.
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