| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID |
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| Generic Name | AID, SURGICAL, VISCOELASTIC |
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| Regulation Number | 886.4275 |
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| Applicant | Altacor , Ltd.
Merlin House, Brunel Rd.
Theale RG7 4AB |
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| PMA Number | P960011 |
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| Date Received | 05/01/1996 |
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| Decision Date | 07/16/1998 |
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| Product Code |
LZP |
| Docket Number | 98M-0604 |
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| Notice Date | 08/17/1998 |
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| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
The device is indicated for use as a surgical aid to protect corneal endothelium during cataract extraction (extra-capsular), intraocular lens implantation and anterior segment surgery. |
| Supplements: |
S018 S019 S022 S003 S009 S001 S002 S004 S005 S006 S008
S010 S013 S012 S014 S015 S016 S017 S027 S028 S029 S030 S031
S011 S026 S024 S020 S007 S023 S025 S032 S021 S034 |
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