PMA P100044S034
- Device
- Propel and Propel Mini Sinus Implants
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S034
- Product code
- OWO
- Decision date
- 2018-09-07
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- Changes to the qualification protocol for the fiber used in the manufacture of 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
- S034
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2018-09-07
- Decision code
- OK30
- Date received
- 2018-08-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the qualification protocol for the fiber used in the manufacture of the Propel and Propel Mini Sinus Implants.