BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)
FDA premarket approval P860022/S052 · decided 2000-02-04
Approval details
- PMA number
- P860022
- Supplement
- S052
- Supplement type
- THIRTY DAY TRACK
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)
- Generic name
- Lens, contact (other material) - daily
- Applicant
- Bausch & Lomb
- Date received
- 2000-01-05
- Decision date
- 2000-02-04
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Approval under a 30-day notice for addition of one finishing laboratory, Procornea Nederland BV, Kollergan9, NL-6961 LZ Eerbeek, The Netherlands, to become an additional manufacturing and distributino site for the referenced devices.
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