FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Lens, Intraocular, Phakic
PMA: P030016
·
Supplement: S038
·
Decision Jul 19, 2019
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Lens, Intraocular, Phakic
- Trade Name
- Visian Toric ICL (Implantable Collamer Lens)
- PMA Number
- P030016
- Supplement Number
- S038
- 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
- July 19, 2019
- Date Received
- May 21, 2019
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval of the revised protocol for the 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 |
|---|---|---|---|
| MTA | Lens, Intraocular, Phakic | FDA class 3 | Unknown |