PERMLENS
FDA premarket approval P780010/S020 · decided 1998-12-04
Approval details
- PMA number
- P780010
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERMLENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1998-10-28
- Decision date
- 1998-12-04
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for a ten (10) year expiration date for the Permalens (perfilcon A) Hydrophilic contact lenses. The device, as modified, will be marketed under the trade name as referenced above with no change in the current indications.
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