INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
FDA premarket approval P980031 · decided 1999-04-09
Approval details
- PMA number
- P980031
- Trade name
- INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
- Generic name
- Implant, corneal, refractive
- Applicant
- Addition Technology
- Date received
- 1998-07-14
- Decision date
- 1999-04-09
- Days to decision
- 269 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lombard, IL
- Statement
- This device is indicated for the reduction or elimination of mild myopia (-2.00 to -3.00 diopters spherical equivalent at the spectacle plane) in patients: who are 21 yrs of age or older; with documented stability of refraction as demonstrated by a change of less than or equal to 0.50D for at least 12 months prior to the preoperative examination; and where the astigmatic components are +1.00D or less.
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