FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS
FDA premarket approval P870024/S025 · decided 1991-06-28
Approval details
- PMA number
- P870024
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS
- Generic name
- Lens, contact (other material) - daily
- Applicant
- CooperVision, Inc.
- Date received
- 1991-04-18
- Decision date
- 1991-06-28
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
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