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.
| Device | RingJect and Capsular Tension Ring (CTR) |
| Generic Name | Ring, Endocapsular |
| Applicant | OPHTEC USA, INC.6421 Congress Ave., Suite 112boca Raton, FL 33487 PMA NumberP030023 Supplement NumberS008 Date Received02/08/2022 Decision Date07/21/2022 Product Code MRJ Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-08 |
| Decision Date | 2022-07-21 |
| PMA | P030023 |
| Supplement | S008 |
| Product Code | MRJ |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OPHTEC USA, INC. 6421 Congress Ave., Suite 112 boca Raton, FL 33487 PMA NumberP030023 Supplement NumberS008 Date Received02/08/2022 Decision Date07/21/2022 Product Code MRJ Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Change To The Processing Agent Used In The Milling Process For The Capsular Tension Ring (CTR) And RingJect |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030023 | Original Filing | |
| S008 | 2022-02-08 | 30-day Notice |
| S007 | 2018-12-18 | 30-day Notice |
| S006 | ||
| S005 | 2016-06-10 | 30-day Notice |
| S004 | 2014-07-21 | Normal 180 Day Track |
| S003 | ||
| S002 | 2012-01-05 | 135 Review Track For 30-day Notice |
| S001 | 2011-10-19 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 08717819070286 | P030023 | 004 |
| 08717819070279 | P030023 | 004 |