PMA P100044S006

Device
PROPEL MINI SINUS IMPLANTS
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S006
Product code
OWO
Decision date
2013-06-10
Classification
Drug-eluting Sinus Stent
Generic name
Drug-eluting sinus stent
Approval order statement
APPROVAL FOR A MANUFACTURING SITE AT INTERSECT ENT, MENLO PARK, CALIFORNIA.

Current openFDA PMA Record#

Device
PROPEL MINI SINUS IMPLANTS
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S006
Product code
OWO
Generic name
Drug-eluting sinus stent
Decision date
2013-06-10
Decision code
APPR
Date received
2012-12-26
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE AT INTERSECT ENT, MENLO PARK, CALIFORNIA.