Additional suppliers for blister packaging which is a part of primary package for the treatment pack
Device | VisuMax Femtosecond Laser |
Generic Name | Femtosecond Laser System For Refractive Correction |
Applicant | Carl Zeiss Meditec, Inc. |
Date Received | 2020-10-29 |
Decision Date | 2020-11-23 |
PMA | P150040 |
Supplement | S007 |
Product Code | OTL |
Advisory Committee | Ophthalmic |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Carl Zeiss Meditec, Inc. 5160 Hacienda Drive dublin, CA 94568 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P150040 | | Original Filing |
S011 |
2022-11-22 |
30-day Notice |
S010 |
2022-05-23 |
30-day Notice |
S009 |
2021-01-25 |
30-day Notice |
S008 |
2020-11-19 |
Normal 180 Day Track |
S007 |
2020-10-29 |
30-day Notice |
S006 |
2020-09-08 |
30-day Notice |
S005 |
2020-03-20 |
30-day Notice |
S004 |
2018-12-11 |
Normal 180 Day Track No User Fee |
S003 |
2018-03-23 |
Panel Track |
S002 |
2018-02-28 |
Real-time Process |
S001 |
2017-01-06 |
Real-time Process |
NIH GUDID Devices