PMA P910071S010

Device: ADATO SIL-OL 5000 SILICONE OIL
Applicant: Bausch & Lomb
PMA number: P910071
Supplement: S010
Product code: LWL
Decision date: 2007-12-12
Generic name: Fluid, intraocular
Approval order statement: APPROVAL FOR A PACKAGING CHANGE WHICH INVOLVES THE ADDITION OF A RIGID TIP CAP TO THE 10 CC GLASS SYRINGE PACKAGING CONFIGURATION TO INCORPORATE A RIGID POLYPROPYLENE HOUSING AROUND THE ELASTOMER SEAL.

Current openFDA PMA Record#

Device: ADATO SIL-OL 5000 SILICONE OIL
Applicant: Bausch & Lomb
PMA number: P910071
Supplement: S010
Product code: LWL
Generic name: Fluid, intraocular
Decision date: 2007-12-12
Decision code: APPR
Date received: 2007-07-11
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A PACKAGING CHANGE WHICH INVOLVES THE ADDITION OF A RIGID TIP CAP TO THE 10 CC GLASS SYRINGE PACKAGING CONFIGURATION TO INCORPORATE A RIGID POLYPROPYLENE HOUSING AROUND THE ELASTOMER SEAL.