POLYMETHYLMETHACRYLATE(PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES

FDA Premarket Approval P960034 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

DevicePOLYMETHYLMETHACRYLATE(PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES
ApplicantABBOTT MEDICAL OPTICS INC
Date Received1999-12-20
Decision Date2000-02-07
PMAP960034
SupplementS001
Advisory CommitteeNeurology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT MEDICAL OPTICS INC 1700 E. St. Andrew Place santa Ana, CA 92705

Supplemental Filings

Supplement NumberDateSupplement Type
P960034Original Filing
S002 2007-04-12 30-day Notice
S001 1999-12-20 Real-time Process

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