PARAGON CRT LENS
FDA premarket approval P050031/S001 · decided 2014-07-28
Approval details
- PMA number
- P050031
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PARAGON CRT LENS
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2010-10-25
- Decision date
- 2014-07-28
- Days to decision
- 1372 days
- Decision code
- APPR
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- APPROVAL FOR A LABELING UPDATE TO THE PACKAGE INSERT AND PATIENT INFORMATION BOOKLET TO INCLUDE THE RESULTS FROM A SECTION 522 POSTMARKET SURVEILLANCE STUDY (PAS).
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