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Device | BIOLON 1% SODIUM HYALURONATE |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Altacor Ltd. Merlin House, Brunel Road Theale RG7 4 |
PMA Number | P960011 |
Supplement Number | S003 |
Date Received | 08/03/1999 |
Decision Date | 09/02/1999 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The 30-Day Notice requested a manufacturing process change for BioLon(TM) (1% sodium hyaluronate). The requested change describes the installation and qualification of an upgrade to Bio-Technology General Corporation's fermentation process at the Rehovot, Israel facility and the validation of the sodium hyaluronate fermentation process after the upgrade. |