PMA P100044S048
- Device
- Propel and Propel Mini Sinus Implants
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S048
- Product code
- OWO
- Decision date
- 2021-04-09
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- Approval for the change of e-beam sterilization dose for the Propel and Propel Mini Sinus Implants.
Current openFDA PMA Record#
- Device
- Propel and Propel Mini Sinus Implants
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S048
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2021-04-09
- Decision code
- APPR
- Date received
- 2021-01-11
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the change of e-beam sterilization dose for the Propel and Propel Mini Sinus Implants.