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 | CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS |
| Generic Name | Intraocular Lens |
| Applicant | STORZ OPHTHALMICS, INC. |
| Date Received | 1987-07-30 |
| Decision Date | 1988-01-27 |
| PMA | P800017 |
| Supplement | S004 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STORZ OPHTHALMICS, INC. 1365 Hamlet Ave. p.o. 2498 clearwater, FL 34616 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800017 | Original Filing | |
| S004 | 1987-07-30 | Normal 180 Day Track |
| S003 | 1987-03-16 | Normal 180 Day Track |
| S002 | 1985-02-19 | |
| S001 |