|
Device | Ophthalmic Viscosurgical Devices |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P840064 |
Supplement Number | S070 |
Date Received | 08/07/2018 |
Decision Date | 03/20/2019 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for use of the Bulk Syringe Line (BSL) as an additional alternate syringe processing and filling line to fill VISCOAT® and VISCOAT® as part of DUOVISC® |