|
Device | BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Altacor Ltd. Merlin House, Brunel Road Theale RG7 4 |
PMA Number | P960011 |
Supplement Number | S005 |
Date Received | 04/25/2000 |
Decision Date | 05/19/2000 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement Sterility release be based on review of documentation of the ethylene oxide sterilization cycle and testing of the biological indicators and that external sterility testing of Biolon syringe surfaces be discontinued. |