X-70 SOFT CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P830047 S002

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

DeviceX-70 SOFT CONTACT LENS
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1987-07-21
Decision Date1987-08-12
PMAP830047
SupplementS002
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 1700 E. St. Andrew Place p.o. Box 25162 santa Ana, CA 92705-4933

Supplemental Filings

Supplement NumberDateSupplement Type
P830047Original Filing
S006 1991-04-18 Normal 180 Day Track
S005
S004 1989-07-20 Normal 180 Day Track
S003 1987-08-04 Normal 180 Day Track
S002 1987-07-21 Normal 180 Day Track
S001 1986-09-12 Normal 180 Day Track

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