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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.
 
DeviceADATO SIL 5000
Classification Namefluid, intraocular
Generic Namefluid, intraocular
Regulation Number886.4275
Applicant
BAUSCH & LOMB
50 technology drive
irvine, CA 92618
PMA NumberP910071
Supplement NumberS002
Date Received12/28/1994
Decision Date07/14/1995
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A PROTOCOL FOR A POSTAPPROVAL PROSPECTIVE STUDY
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