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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceX-70 SOFT CONTACT LENS
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
ADVANCED MEDICAL OPTICS, INC.
1700 e. st. andrew place
p.o. box 25162
santa ana, CA 92705-4933
PMA NumberP830047
Supplement NumberS002
Date Received07/21/1987
Decision Date08/12/1987
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
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