PMA P100044S007

Device
PROPEL AND PROPEL MINI SINUS IMPLANT
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S007
Product code
OWO
Decision date
2013-02-27
Classification
Drug-eluting Sinus Stent
Generic name
Drug-eluting sinus stent
Approval order statement
CHANGES TO TWO QUALITY CONTROL TEST METHODS.

Current openFDA PMA Record#

Device
PROPEL AND PROPEL MINI SINUS IMPLANT
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S007
Product code
OWO
Generic name
Drug-eluting sinus stent
Decision date
2013-02-27
Decision code
OK30
Date received
2013-01-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGES TO TWO QUALITY CONTROL TEST METHODS.