PMA P100044S039

Device
Propel, Propel Mini and Propel Contour Sinus Implants
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S039
Product code
OWO
Decision date
2019-05-23
Classification
Drug-eluting Sinus Stent
Generic name
Drug-eluting sinus stent
Approval order statement
Adding an alternate warehouse facility for the Propel, Propel Mini and Propel Contour Sinus Implants.

Current openFDA PMA Record#

Device
Propel, Propel Mini and Propel Contour Sinus Implants
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S039
Product code
OWO
Generic name
Drug-eluting sinus stent
Decision date
2019-05-23
Decision code
OK30
Date received
2019-04-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding an alternate warehouse facility for the Propel, Propel Mini and Propel Contour Sinus Implants.