PMA P960028S001
- Device
- AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P960028
- Supplement
- S001
- Product code
- MFK
- Decision date
- 1997-10-07
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- Approval to modify the current maximum level of ethylene ixide residual from "not to exceed 25 ppm" to "not to exceed 1.0 ug/lens."
Current openFDA PMA Record#
- Device
- AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P960028
- Supplement
- S001
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 1997-10-07
- Decision code
- APPR
- Date received
- 1997-09-19
- Approval order statement
- Approval to modify the current maximum level of ethylene ixide residual from "not to exceed 25 ppm" to "not to exceed 1.0 ug/lens."