FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Lens, Intraocular, Phakic
PMA: P030016
·
Supplement: S033
·
Decision Aug 4, 2017
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Lens, Intraocular, Phakic
- Trade Name
- Visian Implantable Collamer Lens for Myopia
- PMA Number
- P030016
- Supplement Number
- S033
- 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
- August 4, 2017
- Date Received
- July 6, 2017
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Addition of an autoclave for use in the sterilization of the Visian Implantable Collamer Lens (ICL) and the Collamer Intraocular Lens (CIOL) at the Monrovia, California facility.
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 |