SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)
FDA premarket approval P870051/S006 · decided 1997-06-02
Approval details
- PMA number
- P870051
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE)
- Generic name
- Accessories, soft lens products
- Applicant
- Trp Company
- Date received
- 1996-06-04
- Decision date
- 1997-06-02
- Days to decision
- 363 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Reno, NV
- Statement
- Approval for an expansion of the indications for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.
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