METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT
FDA premarket approval P820026/S005 · decided 1989-03-01
Approval details
- PMA number
- P820026
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Metrosoft, Inc.
- Date received
- 1988-10-28
- Decision date
- 1989-03-01
- Days to decision
- 124 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Austin, TX
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 |
|---|---|---|
| METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC (K983021) | Metrosoft, Inc. | 1998-11-13 |
| METRO 55G TORIC & SPHERICAL (K953199) | Metrosoft, Inc. | 1995-12-11 |