PMA P100044S046
- Device
- Propel Mini Sinus Implant
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S046
- Product code
- OWO
- Decision date
- 2020-07-01
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- Approval for a new packaging configuration and labeling changes for the Propel Mini Sinus Implant.
Current openFDA PMA Record#
- Device
- Propel Mini Sinus Implant
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S046
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2020-07-01
- Decision code
- APPR
- Date received
- 2020-04-02
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a new packaging configuration and labeling changes for the Propel Mini Sinus Implant.