FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Lens, Intraocular, Phakic
PMA: P030016
·
Supplement: S039
·
Decision Jul 26, 2019
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Lens, Intraocular, Phakic
- Trade Name
- Visian Implantable Collamer Lens
- PMA Number
- P030016
- Supplement Number
- S039
- 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
- July 26, 2019
- Date Received
- June 27, 2019
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Addition of the microbiology laboratory at the STAAR Surgical, Monrovia facility, as an alternate provider of environmental monitoring services for cleanrooms used to manufacture and process finished devices.
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 |