FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ring, Endocapsular
PMA: P010059
·
Supplement: S006
·
Decision Jan 26, 2017
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Ring, Endocapsular
- Trade Name
- FortiEYE CAPSULAR TENSION RINGS, TYPES 14, 14A AND 14C
- PMA Number
- P010059
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- MRJ
- Generic Name
- Ring, endocapsular
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 26, 2017
- Date Received
- August 2, 2016
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for new private labeling for an alternative distributor.
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 |
|---|---|---|---|
| MRJ | Ring, Endocapsular | FDA class 3 | Unknown |