NOVALENS (ROSILFOCON A)
FDA premarket approval P890058/S007 · decided 1991-07-19
Approval details
- PMA number
- P890058
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NOVALENS (ROSILFOCON A)
- Generic name
- Lens, contact (other material) - daily
- Applicant
- Ocutec Corporation, Inc.
- Date received
- 1991-02-27
- Decision date
- 1991-07-19
- Days to decision
- 142 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Morrisville, NC
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 |
|---|---|---|
| NOVALENS/NOVAWET PERCEPTION AND VANGUARD (K942533) | Ocutec Corporation, Inc. | 1994-08-05 |