PMA P830037S046
- Device
- PHEMFILCON A
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P830037
- Supplement
- S046
- Product code
- LPM
- Decision date
- 2002-09-04
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- APPROVAL FOR A LABELING MODIFICATION OF THE SECONDARY BOX CARTON TO INCLUDE THE CLAIM "IMPROVED COMFORT".
Current openFDA PMA Record#
- Device
- PHEMFILCON A
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P830037
- Supplement
- S046
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2002-09-04
- Decision code
- APPR
- Date received
- 2002-07-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A LABELING MODIFICATION OF THE SECONDARY BOX CARTON TO INCLUDE THE CLAIM "IMPROVED COMFORT".