FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Drug-Eluting Sinus Stent
PMA: P100044
·
Supplement: S003
·
Decision Nov 9, 2012
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Drug-Eluting Sinus Stent
- Trade Name
- PROPEL MINI SINUS IMPLANT, 6011
- PMA Number
- P100044
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- OWO
- Generic Name
- Drug-eluting sinus stent
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 9, 2012
- Date Received
- October 1, 2012
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MODIFICATIONS TO THE STENT CRIMPER AND DELIVERY SYSTEMACCESSORY COMPONENTS OF THE DEVICE.
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 |
|---|---|---|---|
| OWO | Drug-Eluting Sinus Stent | FDA class 3 | Unknown |