FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES
FDA premarket approval P870024/S041 · decided 1997-08-25
Approval details
- PMA number
- P870024
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES
- Generic name
- Lens, contact (other material) - daily
- Applicant
- CooperVision, Inc.
- Date received
- 1997-05-12
- Decision date
- 1997-08-25
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for Viscon Contact Lens Manufacturing Ltd., 10214-112 Street, Edmonton, Alberta, Canada T5K1M4, as an alternate manufacturing and distribution site for the device.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.