FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ring, Endocapsular
PMA: P010059
·
Supplement: S007
·
Decision Sep 6, 2023
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Ring, Endocapsular
- Trade Name
- MORCHER Capsular Tension Ring, EYEJET CTR, MORCHER Injector
- PMA Number
- P010059
- Supplement Number
- S007
- 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
- September 6, 2023
- Date Received
- September 14, 2022
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for expansion of the Capsular Tension Ring device family to include the new Type 20C Model.
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 |