FDA.reportPublic FDA data

PMA P100044S045

Device
Propel Family of Sinus Implants
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S045
Product code
OWO
Decision date
2020-04-24
Generic name
Drug-eluting sinus stent
Approval order statement
Approval for modifications to the Instructions for Use (IFU) to enhance the safe use of the Propel Family of Implants (Propel, Propel Mini and Propel Contour).

Current openFDA PMA Record#

Device
Propel Family of Sinus Implants
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S045
Product code
OWO
Generic name
Drug-eluting sinus stent
Decision date
2020-04-24
Decision code
APPR
Date received
2020-03-26
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for modifications to the Instructions for Use (IFU) to enhance the safe use of the Propel Family of Implants (Propel, Propel Mini and Propel Contour).