ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS
FDA premarket approval P870019/S002 · decided 1989-12-11
Approval details
- PMA number
- P870019
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Hanita Contact Lens Laboratory
- Date received
- 1989-07-14
- Decision date
- 1989-12-11
- Days to decision
- 150 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- New York, NY
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