Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p930016/s053.
| Device | iDESIGN Refractive Studio and STAR S4 IR Excimer Laser Systems |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | AMO Manufacturing USA, LLC |
| Date Received | 2019-03-29 |
| Decision Date | 2019-05-28 |
| PMA | P930016 |
| Supplement | S059 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AMO Manufacturing USA, LLC 510 Cottonwood Drive milpitas, CA 95035 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P930016 | | Original Filing |
| S062 |
2020-10-01 |
Normal 180 Day Track No User Fee |
| S061 |
2019-11-25 |
Real-time Process |
| S060 |
2019-10-31 |
Real-time Process |
| S059 |
2019-03-29 |
Normal 180 Day Track No User Fee |
| S058 |
2019-01-22 |
Real-time Process |
| S057 | | |
| S056 |
2018-12-31 |
Real-time Process |
| S055 |
2018-07-16 |
Normal 180 Day Track No User Fee |
| S054 |
2017-12-01 |
Real-time Process |
| S053 |
2017-09-29 |
Normal 180 Day Track |
| S052 |
2017-06-12 |
30-day Notice |
| S051 |
2017-05-16 |
Real-time Process |
| S050 |
2017-03-16 |
30-day Notice |
| S049 |
2016-12-27 |
30-day Notice |
| S048 |
2016-12-01 |
Panel Track |
| S047 |
2015-11-17 |
Real-time Process |
| S046 |
2015-10-19 |
Real-time Process |
| S045 |
2015-06-01 |
Panel Track |
| S044 |
2014-11-10 |
Panel Track |
| S043 |
2014-07-07 |
Real-time Process |
| S042 |
2014-05-19 |
30-day Notice |
| S041 | | |
| S040 |
2014-05-01 |
30-day Notice |
| S039 | | |
| S038 |
2013-05-28 |
Special (immediate Track) |
| S037 | | |
| S036 |
2011-10-28 |
30-day Notice |
| S035 |
2011-08-29 |
Normal 180 Day Track |
| S034 |
2010-09-20 |
Normal 180 Day Track |
| S033 | | |
| S032 |
2009-09-18 |
Normal 180 Day Track |
| S031 |
2008-08-11 |
Normal 180 Day Track |
| S030 |
2007-11-21 |
Real-time Process |
| S029 | | |
| S028 |
2007-10-29 |
Normal 180 Day Track No User Fee |
| S027 |
2007-08-08 |
Normal 180 Day Track |
| S026 |
2006-10-24 |
Real-time Process |
| S025 |
2006-09-29 |
Panel Track |
| S024 |
2006-03-30 |
Real-time Process |
| S023 |
2005-08-12 |
Real-time Process |
| S022 |
2005-03-30 |
Real-time Process |
| S021 |
2005-03-08 |
Panel Track |
| S020 |
2004-09-21 |
Panel Track |
| S019 |
2004-09-07 |
Normal 180 Day Track |
| S018 | | |
| S017 |
2003-11-28 |
Panel Track |
| S016 |
2002-10-01 |
Panel Track |
| S015 |
2002-07-30 |
Real-time Process |
| S014 |
2001-06-04 |
Panel Track |
| S013 |
2001-02-05 |
Normal 180 Day Track |
| S012 |
2000-07-14 |
Panel Track |
| S011 |
2000-04-12 |
Real-time Process |
| S010 |
1999-06-18 |
Panel Track |
| S009 | | |
| S008 | | |
| S007 |
1998-03-05 |
Panel Track |
| S006 |
1998-02-26 |
Real-time Process |
| S005 |
1997-07-23 |
Panel Track |
| S004 |
1996-12-17 |
Normal 180 Day Track |
| S003 |
1996-08-26 |
Panel Track |
| S002 |
1996-05-16 |
Normal 180 Day Track |
| S001 |
1996-04-18 |
Normal 180 Day Track |
NIH GUDID Devices