TIER A & B INTRAOCULAR LENSES

FDA Premarket Approval P890068 S001

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.

Pre-market Approval Supplement Details

DeviceTIER A & B INTRAOCULAR LENSES
Generic NameIntraocular Lens
ApplicantCHIRON OPHTHALMICS
Date Received1991-01-24
Decision Date1993-10-22
PMAP890068
SupplementS001
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CHIRON OPHTHALMICS 9342 Jeronimo Rd. irvine, CA 92718

Supplemental Filings

Supplement NumberDateSupplement Type
P890068Original Filing
S001 1991-01-24 Normal 180 Day Track

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