PMA P100044S017

Device
PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S017
Product code
OWO
Decision date
2015-05-07
Classification
Drug-eluting Sinus Stent
Generic name
Drug-eluting sinus stent
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH AST IN DENVER, COLORADO.

Current openFDA PMA Record#

Device
PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S017
Product code
OWO
Generic name
Drug-eluting sinus stent
Decision date
2015-05-07
Decision code
APPR
Date received
2015-04-02
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 LOCATED AT SYNERGY HEALTH AST IN DENVER, COLORADO.