FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Lens, Intraocular, Phakic
PMA: P030028
·
Supplement: S012
·
Decision Jan 18, 2024
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Lens, Intraocular, Phakic
- Trade Name
- ARTISAN Phakic lntraocular Lens (IOL),
- PMA Number
- P030028
- Supplement Number
- S012
- Device Class
- FDA Class 3
- Product Code
- MTA
- Generic Name
- Lens, intraocular, phakic
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- January 18, 2024
- Date Received
- December 21, 2023
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
a change to the supplier of the packaging Tyvek lid
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 |