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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-OL 5000 SILICONE OIL SYRINGE
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantBausch & Lomb
50 Technology Dr.
Irvine, CA 92618
PMA NumberP910071
Supplement NumberS006
Date Received01/29/2002
Decision Date12/23/2002
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 FOR ADATO SIL-OL 5000 SILICONE OIL: 1) ADDITION OF A NEW PRIMARY CONTAINER CLOSURE SYSTEM (GLASS SYRINGE); 2) PHARM PUR GMBH, AUGSBURG, GERMANY, AS THE SITE FOR FILLING, STERILIZATION, LABELING AND PACKAGING FOR ADATO SIL-OL 5000 SILICONE OIL PACKAGED IN A SYRINGE; 3) PARAMETRIC RELEASE OF THE ADATO SIL-OL 5000 SILICONE OIL SYRINGE PACKAGED PRODUCT IN LIEU OF END PRODUCT STERILITY TESTING; AND 4) DOUBLE POUCH PACKAGING FOR ADATO SIL-OL 5000 SILICONE OIL SYRINGE.
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