FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Drug-Eluting Sinus Stent
PMA: P100044
·
Supplement: S044
·
Decision Oct 8, 2019
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Drug-Eluting Sinus Stent
- Trade Name
- Propel, Propel Mini and Propel Contour (Propel Familly) Sinus Implants
- PMA Number
- P100044
- Supplement Number
- S044
- Device Class
- FDA Class 3
- Product Code
- OWO
- Generic Name
- Drug-eluting sinus stent
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- October 8, 2019
- Date Received
- September 10, 2019
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
New packaging vision inspection system.
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 |