FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ring, Endocapsular
PMA: P010059
·
Supplement: S001
·
Decision Mar 15, 2004
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Ring, Endocapsular
- Trade Name
- ALCON REFORM CAPSULAR TENSION RING
- PMA Number
- P010059
- Supplement Number
- S001
- 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
- March 15, 2004
- Date Received
- January 20, 2004
- 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 A PRIVATE LABEL DISTRIBUTOR AGREEMENT WITH ALCON LABORATORIES, INC., FORT WORTH, TEXAS. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME ALCON REFORM CAPSULAR TENSION RINGS (MODELS ACTR10, ACTR11, AND ACTR12).
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 |