PMA P100044S018
- Device
- PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S018
- Product code
- OWO
- Decision date
- 2016-03-23
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- Approval for the PROPEL Mini Sinus Implant is intended for use in patients >= 18 years of age following ethmoid/frontal sinus surgery to maintain patency of the ethmoid sinus or frontal sinus opening. The PROPEL Mini Sinus Implant separates/dilates surrounding mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces inflammation. 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/P100044S018B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S018
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2016-03-23
- Decision code
- APPR
- Date received
- 2015-09-25
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the PROPEL Mini Sinus Implant is intended for use in patients >= 18 years of age following ethmoid/frontal sinus surgery to maintain patency of the ethmoid sinus or frontal sinus opening. The PROPEL Mini Sinus Implant separates/dilates surrounding mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces inflammation. The implant reduces the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.