This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the technolas 217a excimer laser system. The device uses an optical zone treatment range from 5. 00 mm to 6. 00 mm with a blend zone of 1. 90 mm for spherical hyperopia and 1. 75 mm for hyperopic astigmatism. The laser is locked out for refractive corrections greater than +4. 00 d sphere and greater than +2. 00 d cylinder. The device is indicated for laser in-situ keratomileusis (lasik) treatments: 1) for the reduction or elimination of low-to-moderate naturally occurring hyperopia up to +4. 00 diopters (d) mrse, with sphere between +1. 00 to +4,00 d with or without refractive astigmatism up to +2. 00 d at the spectacle plane; 2) in patients who are 21 years of age or older; and, 3) in patients with documented evidence of a change in manifest refraction of less than or equal to 0. 50 diopters (in both cylinder and sphere components) for at least one year prior to the date of the pre-operative examination.
| Device | TECHNOLAS 217A EXCIMER LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | TECHNOLAS PERFECT VISION GMBH |
| Date Received | 2001-12-14 |
| Decision Date | 2003-02-25 |
| Notice Date | 2003-04-28 |
| PMA | P990027 |
| Supplement | S004 |
| Product Code | LZS |
| Docket Number | 03M-0174 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TECHNOLAS PERFECT VISION GMBH messerschmittstr 1 + 3 munchen 80992 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990027 | Original Filing | |
| S020 | 2015-10-07 | 30-day Notice |
| S019 | 2014-01-31 | 30-day Notice |
| S018 | 2012-05-01 | Normal 180 Day Track |
| S017 | 2012-04-26 | Real-time Process |
| S016 | 2010-09-17 | 135 Review Track For 30-day Notice |
| S015 | 2010-06-29 | Normal 180 Day Track |
| S014 | ||
| S013 | 2009-10-01 | Real-time Process |
| S012 | 2009-05-15 | Normal 180 Day Track No User Fee |
| S011 | 2008-09-03 | Normal 180 Day Track |
| S010 | 2008-08-11 | Normal 180 Day Track |
| S009 | 2006-12-19 | Normal 180 Day Track |
| S008 | ||
| S007 | 2004-09-10 | Normal 180 Day Track |
| S006 | 2002-07-18 | Panel Track |
| S005 | 2002-01-31 | Normal 180 Day Track |
| S004 | 2001-12-14 | Panel Track |
| S003 | 2001-04-27 | Normal 180 Day Track |
| S002 | 2000-11-24 | Panel Track |
| S001 | 2000-10-13 | Normal 180 Day Track |