PMA P100044S013
- Device
- PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S013
- Product code
- OWO
- Decision date
- 2014-01-09
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- APPROVAL FOR A DESIGN MODIFICATION TO THE DELIVERY SYSTEM ACCESSORYCOMPONENT OF THE PREVIOUSLY APPROVED PROPEL MINI SINUS IMPLANT.
Current openFDA PMA Record#
- Device
- PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S013
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2014-01-09
- Decision code
- APPR
- Date received
- 2013-11-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A DESIGN MODIFICATION TO THE DELIVERY SYSTEM ACCESSORYCOMPONENT OF THE PREVIOUSLY APPROVED PROPEL MINI SINUS IMPLANT.