SOFTACT II (POLYMACON)
FDA premarket approval P830006/S006 · decided 1992-04-15
Approval details
- PMA number
- P830006
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOFTACT II (POLYMACON)
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Premier Contact Lens
- Date received
- 1992-02-18
- Decision date
- 1992-04-15
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Nashville, TN
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