| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | PERFLUORON |
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| Classification Name | fluid, intraocular |
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| Generic Name | liquid ultrapure perfluoro-n-octane (pfno) |
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| Regulation Number | 886.4275 |
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| Applicant | ALCON LABORATORIES |
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| PMA Number | P950018 |
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| Supplement Number | S006 |
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| Date Received | 04/24/2001 |
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| Decision Date | 05/15/2001 |
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| Product Code | |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | 30-day notice |
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| Supplement Reason | process change: manufacturing |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Elimination of redundant in process testing for %pfno, fluoride ion, non-volatile residues and heavy metals. |
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