FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Lens, Intraocular, Accommodative
PMA: P030002
·
Supplement: S039
·
Decision Apr 8, 2022
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Lens, Intraocular, Accommodative
- Trade Name
- Trulign® Toric Posterior Chamber Intraocular Lens (IOL)
- PMA Number
- P030002
- Supplement Number
- S039
- Device Class
- FDA Class 3
- Product Code
- NAA
- Generic Name
- Lens, intraocular, accommodative
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 8, 2022
- Date Received
- October 12, 2021
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - PAS
- Expedited Review
- N
Advisory Committee Statement
Approval for revised device labeling to describe results of the New Enrollment Study Post Approval Study (PAS) protocol.
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 |
|---|---|---|---|
| NAA | Lens, Intraocular, Accommodative | FDA class 3 | Ophthalmic |