ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval P870019 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

• Device: ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS
• Classification Name: Lenses, Soft Contact, Daily Wear
• Generic Name: Lenses, Soft Contact, Daily Wear
• Applicant: HANITA CONTACT LENS LABORATORY
• Date Received: 1989-07-14
• Decision Date: 1989-12-11
• PMA: P870019
• Supplement: S002
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: HANITA CONTACT LENS LABORATORY 333 East 57th St. new York, NY 10022

Supplemental Filings

Supplement Number	Date	Supplement Type
P870019		Original Filing
S003	1989-09-12	Normal 180 Day Track
S002	1989-07-14	Normal 180 Day Track
S001	1989-04-28	Normal 180 Day Track