|
Device | VisuMax Femtosecond Laser |
Generic Name | Femtosecond laser system for refractive correction |
Applicant | Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 |
PMA Number | P150040 |
Supplement Number | S007 |
Date Received | 10/29/2020 |
Decision Date | 11/23/2020 |
Product Code |
OTL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Additional suppliers for blister packaging which is a part of primary package for the Treatment Pack. |