Atlas FDA

MODEL P-17 MOD. C LOOP W/NOTCH POSTERIOR CHAMBER

FDA premarket approval P880072/S005 · decided 1989-10-23

Approval details

PMA number
P880072
Supplement
S005
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
MODEL P-17 MOD. C LOOP W/NOTCH POSTERIOR CHAMBER
Generic name
intraocular lens
Applicant
Eyekon Medical, Inc.
Date received
1988-12-13
Decision date
1989-10-23
Days to decision
314 days
Decision code
APPR
Product code
HQL
Advisory committee
Ophthalmic
Expedited review
No
Location
Clearwater, FL

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510(k) clearances by this applicant

RecordFirmDate
Temporary Keratoprosthesis (QuickSet TKP™) (K261312)Eyekon Medical, Inc.2026-07-24