VITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE)
FDA premarket approval P910068/S001 · decided 2001-04-04
Approval details
- PMA number
- P910068
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE)
- Generic name
- Fluid, intraocular
- Applicant
- Air Products & Chemicals, Inc.
- Date received
- 1999-04-26
- Decision date
- 2001-04-04
- Days to decision
- 709 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Allentown, PA
- Statement
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| COPPER KETTLE VAPORIZER PLUS (K771150) | Air Products & Chemicals, Inc. | 1977-08-04 |
| ANESTHESIA BREATHING CIRCUIT (K771134) | Air Products & Chemicals, Inc. | 1977-07-05 |