PMA P100044S023
- Device
- PROPEL CONTOUR SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S023
- Product code
- OWO
- Decision date
- 2017-02-23
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- Approval of the PROPEL Contour Sinus Implant. This device is indicated for use in patients greater than or equal to 18 years of age to maintain patency of the frontal and maxillary sinus ostia following sinus surgery and locally deliver steroids to the sinus mucosa. The PROPEL Contour Sinus Implant separates/dilates mucosal tissues, prevents obstruction by adhesions/scarring, and reduces edema. The implant reduces the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100044S023B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- PROPEL CONTOUR SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S023
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2017-02-23
- Decision code
- APPR
- Date received
- 2016-08-01
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of the PROPEL Contour Sinus Implant. This device is indicated for use in patients greater than or equal to 18 years of age to maintain patency of the frontal and maxillary sinus ostia following sinus surgery and locally deliver steroids to the sinus mucosa. The PROPEL Contour Sinus Implant separates/dilates mucosal tissues, prevents obstruction by adhesions/scarring, and reduces edema. The implant reduces the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.