PMA P960028S003
- Device
- AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P960028
- Supplement
- S003
- Product code
- MFK
- Decision date
- 1999-02-24
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- Approval for changes to the physician and patient labeling.
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
- S003
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 1999-02-24
- Decision code
- APPR
- Date received
- 1998-08-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the physician and patient labeling.