FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ring, Endocapsular
PMA: P010059
·
Supplement: S004
·
Decision May 23, 2013
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Ring, Endocapsular
- Trade Name
- EYEJET INJECTOR
- PMA Number
- P010059
- Supplement Number
- S004
- 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
- May 23, 2013
- Date Received
- November 8, 2011
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE EXPANSION OF YOUR FAMILY OF CAPSULAR TENSION RINGS (CTRS) AVAILABLE PRE-LOADED ON THE EYEJET INJECTOR TO INCLUDE NEW CTR MODELS TYPE 10G, 10L, 15, 15A, AND 15B. IN ADDITION, YOU REQUESTED APPROVAL TO SUPPLY CURRENTLY APPROVED CTR TYPE 10C AS PRE-LOADED ON THE EYEJET INJECTOR.
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 |