PMA P100044S024
- Device
- PROPEL, PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S024
- Product code
- OWO
- Decision date
- 2016-10-28
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- Implementation of alternate analytical testing facilities for finished goods and components used in the manufacture of the Propel and Propel Mini Sinus Implants.
Current openFDA PMA Record#
- Device
- PROPEL, PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S024
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2016-10-28
- Decision code
- OK30
- Date received
- 2016-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of alternate analytical testing facilities for finished goods and components used in the manufacture of the Propel and Propel Mini Sinus Implants.