ADATO SIL-OIL 5000 SILICONE OIL
FDA premarket approval P910071/S005 · decided 2001-03-22
Approval details
- PMA number
- P910071
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADATO SIL-OIL 5000 SILICONE OIL
- Generic name
- Fluid, intraocular
- Applicant
- Bausch & Lomb
- Date received
- 2000-06-05
- Decision date
- 2001-03-22
- Days to decision
- 290 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES: 1) CHANGE OF MANUFACTURING SITE TO PHARM PUR GMBH, AUGSBURG, GERMANY 2) SPECIFICATION REVISIONS: A) CHANGE TO THE FOLLWOING SPECIFICATIONS: VISCOSITY; RESISTIVITY; AND CONTEND OF OLIGOSILOXANES; AND B) ADDITION OF THE FOLLOWING SPECIFICATIONS AND THEIR TEST METHODS; CONTENT OF CATALYST; HEAVY METALS; ENDOTOXINS; ACID CONTENT; CYTOTOXIDITY AND ACETONE 3) CHANGE IN THE FOLLOWING METHOD: DETERMINATION OF CONTENT OF OH-END GROUPS (CHANGED FROM HNMR TO KARL FISHER
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