Biomedics38 (polymacon) Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval P780007/S060 · decided 2018-06-01
Approval details
- PMA number
- P780007
- Supplement
- S060
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Biomedics38 (polymacon) Soft (Hydrophilic) Extended Wear Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2018-03-05
- Decision date
- 2018-06-01
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- Approval for 1) Removal of assay (% NaCl) test requirement from the in-process packaging solution specification; and 2) Addition of osmolality specification to the post-autoclave packaging solution specification.
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