PMA P100044S029
- Device
- PROPEL Contour Sinus Implant Delivery System
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S029
- Product code
- OWO
- Decision date
- 2017-06-28
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- Changes to the tip molding and the applicator forming manufacturing processes for the Propel Contour Sinus Implant Delivery System.
Current openFDA PMA Record#
- Device
- PROPEL Contour Sinus Implant Delivery System
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S029
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2017-06-28
- Decision code
- OK30
- Date received
- 2017-05-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the tip molding and the applicator forming manufacturing processes for the Propel Contour Sinus Implant Delivery System.