LOMBART (POLYMACON)POLYMER BUTTONS & LATHE LL-38L
FDA premarket approval P880102/S002 · decided 1993-05-05
Approval details
- PMA number
- P880102
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LOMBART (POLYMACON)POLYMER BUTTONS & LATHE LL-38L
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Lombart Lenses, Ltd.
- Date received
- 1991-12-20
- Decision date
- 1993-05-05
- Days to decision
- 502 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Norfolk, VA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LL BI-FOCAL, DAILY WEAR CONTACT LENS (K971647) | Lombart Lenses, Ltd. | 1997-07-15 |
| SOFT-55 DAILY WEAR CONTACT LENS (K961428) | Lombart Lenses, Ltd. | 1996-05-21 |
| LL-55 (METHAFILCON A) FOR DAILY WEAR (K941877) | Lombart Lenses, Ltd. | 1994-06-14 |