|
Device | DUOVISC VISCOELASTIC SYSTEM |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P840064 |
Supplement Number | S025 |
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 | Yes |
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. |