PMA P100044S001

Device: PROPEL MINI SINUS IMPLANT
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S001
Product code: OWO
Decision date: 2012-09-21
Classification: Drug-eluting Sinus Stent
Generic name: Drug-eluting sinus stent
Approval order statement: APPROVAL FOR A SHORTENED VERSION OF THE DRUG-ELUTING SINUS STENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROPEL MINI SINUS IMPLANT AND IS INDICATED FOR USE IN PATIENTS >= 18 YEARS OF AGE FOLLOWING ETHMOID SINUS SURGERY TO MAINTAIN PATENCY, THEREBY REDUCING THE NEED FOR POST-OPERATIVE INTERVENTION SUCH AS SURGICAL ADHESION LYSIS AND/OR USE OF ORAL STEROIDS. THE PROPEL MINI SINUS IMPLANT SEPARATES MUCOSAL TISSUES, PROVIDES STABILIZATION OF THE MIDDLE TURBINATE, PREVENTS OBSTRUCTION BY ADHESIONS, AND REDUCES EDEMA.

Current openFDA PMA Record#

Device: PROPEL MINI SINUS IMPLANT
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S001
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2012-09-21
Decision code: APPR
Date received: 2012-03-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A SHORTENED VERSION OF THE DRUG-ELUTING SINUS STENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROPEL MINI SINUS IMPLANT AND IS INDICATED FOR USE IN PATIENTS >= 18 YEARS OF AGE FOLLOWING ETHMOID SINUS SURGERY TO MAINTAIN PATENCY, THEREBY REDUCING THE NEED FOR POST-OPERATIVE INTERVENTION SUCH AS SURGICAL ADHESION LYSIS AND/OR USE OF ORAL STEROIDS. THE PROPEL MINI SINUS IMPLANT SEPARATES MUCOSAL TISSUES, PROVIDES STABILIZATION OF THE MIDDLE TURBINATE, PREVENTS OBSTRUCTION BY ADHESIONS, AND REDUCES EDEMA.