SOFTACT II (POLYMACON)
FDA premarket approval P830006/S007 · decided 1994-03-01
Approval details
- PMA number
- P830006
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SOFTACT II (POLYMACON)
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Premier Contact Lens
- Date received
- 1994-01-26
- Decision date
- 1994-03-01
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Nashville, TN
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