PERMALENS (PERFILCON A)
FDA premarket approval P780010/S021 · decided 1999-05-12
Approval details
- PMA number
- P780010
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERMALENS (PERFILCON A)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1999-04-19
- Decision date
- 1999-05-12
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for a consolidated package insert.
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