FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Ring, Endocapsular
PMA: P010059
·
Supplement: S010
·
Decision Aug 17, 2023
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Ring, Endocapsular
- Trade Name
- MORCHER ® EYEJET ® CTR
- PMA Number
- P010059
- Supplement Number
- S010
- Device Class
- FDA Class 3
- Product Code
- MRJ
- Generic Name
- Ring, endocapsular
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 17, 2023
- Date Received
- July 24, 2023
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Configuration change to the gamma radiation sterilization.
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 |