PMA P100044S060
- Device
- Propel Family Products
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S060
- Product code
- OWO
- Decision date
- 2026-09-23
- Classification
- Ear, Nose, Throat
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- Approval for a shelf-life extension of the Propel Family Products from 24 months to 36 months
Current openFDA PMA Record#
- Device
- Propel Family Products
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S060
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2026-09-23
- Decision code
- APPR
- Date received
- 2026-06-26
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a shelf-life extension of the Propel Family Products from 24 months to 36 months