FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Lenses, Soft Contact, Extended Wear
PMA: P080011
·
Supplement: S184
·
Decision Aug 20, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Lenses, Soft Contact, Extended Wear
- Trade Name
- up&up Monthly Performance +
- PMA Number
- P080011
- Supplement Number
- S184
- Device Class
- FDA Class 3
- Product Code
- LPM
- Generic Name
- Lenses, soft contact, extended wear
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 20, 2025
- Date Received
- February 25, 2025
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
approval for trade name change for CooperVision comfilcon A soft (hydrophilic) contact lenses for extended wear to add up&up Monthly Performance + (intended for the aspherical lens design)
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPM | Lenses, Soft Contact, Extended Wear | FDA class 3 | Ophthalmic |