ARRAY MULTIFOCAL ULTRAVIOLET ABSORBING SILICONE POSTERIOR CHAMBER IOL
FDA premarket approval P960028/S007 · decided 2002-05-01
Approval details
- PMA number
- P960028
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- ARRAY MULTIFOCAL ULTRAVIOLET ABSORBING SILICONE POSTERIOR CHAMBER IOL
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2001-11-19
- Decision date
- 2002-05-01
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ALTERNATE STERILIZATION FACILITY LOCATED AT EDWARDS LIFESCIENCES LLC, ANASCO, PUERTO RICO.
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