INTACS PRESCRIPTION INSERTS
FDA premarket approval P980031/S004 · decided 2001-10-11
Approval details
- PMA number
- P980031
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTACS PRESCRIPTION INSERTS
- Generic name
- Implant, corneal, refractive
- Applicant
- Addition Technology
- Date received
- 2000-02-23
- Decision date
- 2001-10-11
- Days to decision
- 596 days
- Decision code
- APPR
- Product code
- LQE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lombard, IL
- Statement
- APPROVAL FOR 0.275 MM AND 0.325 MM INTACS(TM) AS WELL AS FOR A NEW TRADE NAME, "INTACS(TM) PRESCRIPTION INSERTS."
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