Atlas FDA

GELFLEX(R) (DIMEFILCON A) CONTACT LENS

FDA premarket approval N17722/S004 · decided 1980-03-14

Approval details

PMA number
N17722
Supplement
S004
Trade name
GELFLEX(R) (DIMEFILCON A) CONTACT LENS
Generic name
Lenses, soft contact, daily wear
Applicant
Dow Corning Ophthalmics, Inc.
Date received
1979-10-30
Decision date
1980-03-14
Days to decision
136 days
Decision code
APPR
Product code
LPL
Advisory committee
Ophthalmic
Expedited review
No
Location
Midland, MI

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.