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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-OIL 5000 SILICONE OIL
Classification Namefluid, intraocular
Generic Namefluid, intraocular
Regulation Number886.4275
Applicant
BAUSCH & LOMB
50 technology drive
irvine, CA 92618
PMA NumberP910071
Supplement NumberS005
Date Received06/05/2000
Decision Date03/22/2001
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE FOLLOWING CHANGES: 1) CHANGE OF MANUFACTURING SITE TO PHARM PUR GMBH, AUGSBURG, GERMANY 2) SPECIFICATION REVISIONS: A) CHANGE TO THE FOLLWOING SPECIFICATIONS: VISCOSITY; RESISTIVITY; AND CONTEND OF OLIGOSILOXANES; AND B) ADDITION OF THE FOLLOWING SPECIFICATIONS AND THEIR TEST METHODS; CONTENT OF CATALYST; HEAVY METALS; ENDOTOXINS; ACID CONTENT; CYTOTOXIDITY AND ACETONE 3) CHANGE IN THE FOLLOWING METHOD: DETERMINATION OF CONTENT OF OH-END GROUPS (CHANGED FROM HNMR TO KARL FISHER TITRATION).
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