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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.
 
DeviceBIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAltacor , Ltd.
Merlin House, Brunel Rd.
Theale RG7 4AB
PMA NumberP960011
Supplement NumberS007
Date Received08/08/2001
Decision Date11/01/2002
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW STERILIZATION FACILITY LOCATED AT MEDIPLAST ISRAEL, LTD., YAVNEM, ISRAEL
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