FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
PMA: P190009
·
Supplement: S001
·
Decision Feb 12, 2021
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
- Trade Name
- OPRA Implant System
- PMA Number
- P190009
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- PJY
- Generic Name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 12, 2021
- Date Received
- January 15, 2021
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval of the protocol for the post-approval study (PAS) protocol.
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 |
|---|---|---|---|
| PJY | Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees | FDA class 3 | Unknown |