FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Lens, Intraocular, Phakic
PMA: P030028
·
Supplement: S004
·
Decision Aug 20, 2018
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Lens, Intraocular, Phakic
- Trade Name
- ARTISAN/Verisyse Myopia Phakic Intraocular Lens (IOL)
- PMA Number
- P030028
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- MTA
- Generic Name
- Lens, intraocular, phakic
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 20, 2018
- Date Received
- January 31, 2017
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - PAS
- Expedited Review
- N
Advisory Committee Statement
Approval for modifying the physician and patient labeling to include the results from the new enrollment post-approval study.
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 |
|---|---|---|---|
| MTA | Lens, Intraocular, Phakic | FDA class 3 | Unknown |