PMA P100044S061
- Device
- PROPEL
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S061
- Product code
- OWO
- Decision date
- 2026-09-22
- Classification
- Ear, Nose, Throat
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- approval to implement an automated vision sensor for inspection of correct or incorrect packaging orientation for the Propel Product Family when placed in a shipper
Current openFDA PMA Record#
- Device
- PROPEL
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S061
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2026-09-22
- Decision code
- OK30
- Date received
- 2026-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to implement an automated vision sensor for inspection of correct or incorrect packaging orientation for the Propel Product Family when placed in a shipper