PMA P100044S031

Device: PROPEL Contour SInus Implant
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S031
Product code: OWO
Decision date: 2017-10-13
Classification: Drug-eluting Sinus Stent
Generic name: Drug-eluting sinus stent
Approval order statement: Approval for labeling modifications to clarify instructions for an alternative implant loading method into the delivery system, and for appropriately orienting the delivery system distal tip for the specific sinus being treated.

Current openFDA PMA Record#

Device: PROPEL Contour SInus Implant
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S031
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2017-10-13
Decision code: APPR
Date received: 2017-09-08
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling modifications to clarify instructions for an alternative implant loading method into the delivery system, and for appropriately orienting the delivery system distal tip for the specific sinus being treated.