PMA P100044S005

Device
PROPEL MINI SINUS IMPLANT
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S005
Product code
OWO
Decision date
2013-01-17
Classification
Drug-eluting Sinus Stent
Generic name
Drug-eluting sinus stent
Approval order statement
CHANGE TO THE PACKAGING PROCESS.

Current openFDA PMA Record#

Device
PROPEL MINI SINUS IMPLANT
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S005
Product code
OWO
Generic name
Drug-eluting sinus stent
Decision date
2013-01-17
Decision code
OK30
Date received
2012-12-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO THE PACKAGING PROCESS.