ADATO SIL-OL 5000 SILICONE OIL SYRINGE
FDA premarket approval P910071/S006 · decided 2002-12-23
Approval details
- PMA number
- P910071
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADATO SIL-OL 5000 SILICONE OIL SYRINGE
- Generic name
- Fluid, intraocular
- Applicant
- Bausch & Lomb
- Date received
- 2002-01-29
- Decision date
- 2002-12-23
- Days to decision
- 328 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES FOR ADATO SIL-OL 5000 SILICONE OIL: 1) ADDITION OF A NEW PRIMARY CONTAINER CLOSURE SYSTEM (GLASS SYRINGE); 2) PHARM PUR GMBH, AUGSBURG, GERMANY, AS THE SITE FOR FILLING, STERILIZATION, LABELING AND PACKAGING FOR ADATO SIL-OL 5000 SILICONE OIL PACKAGED IN A SYRINGE; 3) PARAMETRIC RELEASE OF THE ADATO SIL-OL 5000 SILICONE OIL SYRINGE PACKAGED PRODUCT IN LIEU OF END PRODUCT STERILITY TESTING; AND 4) DOUBLE POUCH PACKAGING FOR ADATO SIL-OL 5000 SILICONE OIL SYRINGE
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