HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES
FDA premarket approval P850079/S028 · decided 1996-08-01
Approval details
- PMA number
- P850079
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- CooperVision, Inc.
- Date received
- 1996-07-12
- Decision date
- 1996-08-01
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- APPROVAL FOR REFORMATTING THE PACKAGE INSERT, PROFESSIONAL FITTING AND INFORMATION GUIDE, AND PATIENT INSTRUCTIONS. THE MODIFIED LABELING DOES NOT RESULT IN CHANGES IN THE INDICATIONS FOR USE FOR THE DEVICES
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