Transfer of distribution, product release, secondary labeling and packaging, and limited secondary labeling and secondary packaging rework operations fromthe firms current facility to its new facility.
| Device | INTACS CORNEAL IMPLANTS |
| Classification Name | Implant, Corneal, Refractive |
| Generic Name | Implant, Corneal, Refractive |
| Applicant | ADDITION TECHNOLOGY |
| Date Received | 2012-12-12 |
| Decision Date | 2013-06-03 |
| PMA | P980031 |
| Supplement | S012 |
| Product Code | LQE |
| Advisory Committee | Ophthalmic |
| Supplement Type | 135 Review Track For 30-day Notice |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADDITION TECHNOLOGY 820 Oak Creek Drive lombard, IL 60148 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P980031 | | Original Filing |
| S012 |
2012-12-12 |
135 Review Track For 30-day Notice |
| S011 |
2012-11-14 |
30-day Notice |
| S010 | | |
| S009 |
2005-10-31 |
30-day Notice |
| S008 |
2004-06-10 |
Normal 180 Day Track No User Fee |
| S007 |
2004-05-19 |
Normal 180 Day Track No User Fee |
| S006 |
2003-05-14 |
Normal 180 Day Track No User Fee |
| S005 |
2003-05-02 |
30-day Notice |
| S004 |
2000-02-23 |
Normal 180 Day Track |
| S003 |
2000-02-22 |
30-day Notice |
| S002 |
1999-12-23 |
30-day Notice |
| S001 |
1999-11-03 |
30-day Notice |
NIH GUDID Devices