FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Drug-Eluting Sinus Stent
PMA: P100044
·
Supplement: S006
·
Decision Jun 10, 2013
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Drug-Eluting Sinus Stent
- Trade Name
- PROPEL MINI SINUS IMPLANTS
- PMA Number
- P100044
- Supplement Number
- S006
- 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
- June 10, 2013
- Date Received
- December 26, 2012
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MANUFACTURING SITE AT INTERSECT ENT, MENLO PARK, CALIFORNIA.
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 |