PMA P100044S003
- Device
- PROPEL MINI SINUS IMPLANT, 6011
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S003
- Product code
- OWO
- Decision date
- 2012-11-09
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE STENT CRIMPER AND DELIVERY SYSTEMACCESSORY COMPONENTS OF THE DEVICE.
Current openFDA PMA Record#
- Device
- PROPEL MINI SINUS IMPLANT, 6011
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S003
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2012-11-09
- Decision code
- APPR
- Date received
- 2012-10-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE STENT CRIMPER AND DELIVERY SYSTEMACCESSORY COMPONENTS OF THE DEVICE.