comfilcon A
FDA premarket approval P080011/S088 · decided 2019-01-28
Approval details
- PMA number
- P080011
- Supplement
- S088
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- comfilcon A
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2019-01-03
- Decision date
- 2019-01-28
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Introduction and validation of a new secondary packaging line at the CooperVision Manufacturing, Inc., labeling and packaging facility at West Henrietta, New York.
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