SGP LENS(TM)
FDA premarket approval P840055/S009 · decided 1988-05-10
Approval details
- PMA number
- P840055
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SGP LENS(TM)
- Generic name
- Lens, contact (other material) - daily
- Applicant
- The Lifestyle Co., Inc.
- Date received
- 1988-01-12
- Decision date
- 1988-05-10
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Morganville, NJ
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED) (K000529) | The Lifestyle Co., Inc. | 2000-03-21 |
| LIFESTYLE BREAK THRU (POLYMACON) (K965012) | The Lifestyle Co., Inc. | 1997-03-11 |