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.
Approval for 1) manufacturing site change: the new site for manufacturing the bulk medical grade perfluoroperhydrophenanthrene (apf-215m) will be at fluoromed, l. P. (fmlp), round rock, texas 78664; 2) manufacturing change: apf-215m will be manufactured from perfluoroperhydrophenanthrene raw material instead of from phenanthrene raw material; and 3) apf-215m specification change regarding testing parameter for lower boiling components.
| Device | VITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE) |
| Generic Name | Fluid, Intraocular |
| Applicant | AIR PRODUCTS & CHEMICALS, INC. |
| Date Received | 1999-04-26 |
| Decision Date | 2001-04-04 |
| PMA | P910068 |
| Supplement | S001 |
| Product Code | LWL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AIR PRODUCTS & CHEMICALS, INC. 7201 Hamilton Blvd. allentown, PA 18951-501 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910068 | Original Filing | |
| S001 | 1999-04-26 | Normal 180 Day Track |