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 | PROVISC OPHTHALMIC VICOSURGICAL DEVICE |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Alcon Research, Ltd. 6201 SOUTH FREEWAY, R3-48 FORT WORTH, TX 76134-2099 |
PMA Number | P890047 |
Supplement Number | S016 |
Date Received | 02/17/2004 |
Decision Date | 03/05/2004 |
Product Code |
LZP |
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 TO MODIFY THE PH RELEASE AND STABILITY SPECIFICATION RANGES FOR PROVISC OPHTHALMIC VISCOSURGICAL DEVICE CONTAINED WITHIN THE DUOVISC VISCOELASTIC SYSTEM FROM PH 7.0-7.3 TO PH 7.0-7.4 FOR RELEASE AND PH 7.0-7.5 TO PH 6.8-7.5 FOR STABILITY. |
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