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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
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantBausch & Lomb
50 Technology Dr.
Irvine, CA 92618
PMA NumberP910071
Supplement NumberS005
Date Received06/05/2000
Decision Date03/22/2001
Product Code LWL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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