Note: 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. |
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Device | ADATO SIL-OL 5000 SILICONE OIL |
Generic Name | Fluid, intraocular |
Regulation Number | 886.4275 |
Applicant | BAUSCH & LOMB 50 Technology Drive Irvine, CA 92618 |
PMA Number | P910071 |
Supplement Number | S010 |
Date Received | 07/11/2007 |
Decision Date | 12/12/2007 |
Product Code |
LWL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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