MODELS 011 & 011B IRIDOCAPSULAR IOLS
FDA premarket approval P810042 · decided 1982-12-15
Approval details
- PMA number
- P810042
- Trade name
- MODELS 011 & 011B IRIDOCAPSULAR IOLS
- Generic name
- intraocular lens
- Applicant
- Pharmacia, Inc.
- Date received
- 1981-08-17
- Decision date
- 1982-12-15
- Days to decision
- 485 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ALLERGAN IMMUNO CAP M4, M8, K70 (K974350) | Pharmacia, Inc. | 1998-02-09 |
| UNICAP PHADIATOP (K972364) | Pharmacia, Inc. | 1997-09-04 |
| UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 (K972068) | Pharmacia, Inc. | 1997-07-03 |
| MASTERCAP AM 5.0/MASTERCAP RM 5.0 (K970420) | Pharmacia, Inc. | 1997-06-30 |
| UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH (K964152) | Pharmacia, Inc. | 1997-04-23 |
| UNICAP 100 (K962274) | Pharmacia, Inc. | 1996-09-12 |
| PHARMACIA CAP SYSTEM PHADIATOP FEIA (K941993) | Pharmacia, Inc. | 1996-01-30 |
| GENOTROPIN MIXER (K954337) | Pharmacia, Inc. | 1995-11-13 |