- Device
- SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)
- Applicant
- Trp Company
- PMA number
- P870051
- Supplement
- S006
- Product code
- LPN
- Generic name
- Accessories, soft lens products
- Decision date
- 1997-06-02
- Decision code
- APPR
- Date received
- 1996-06-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an expansion of the indications for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.