BIOCURVE SOFT CONTACT LENSES
FDA premarket approval P860040/S016 · decided 2004-05-28
Approval details
- PMA number
- P860040
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- BIOCURVE SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Wavetouch Technologies, LLC
- Date received
- 2004-05-05
- Decision date
- 2004-05-28
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL TO RELOCATE SOME MANUFACTURING PROCESSES TO THE SITE LOCATED AT AMERICAN BIOCURVE, INC., SAN DIEGO, CALIFORNIA.
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