PMA P100044S015

Device
PROPEL AND PROPEL MINI SINUS IMPLANTS
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S015
Product code
OWO
Decision date
2014-02-11
Classification
Drug-eluting Sinus Stent
Generic name
Drug-eluting sinus stent
Approval order statement
ALTERNATE SUPPLIER BE CLEARED.

Current openFDA PMA Record#

Device
PROPEL AND PROPEL MINI SINUS IMPLANTS
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S015
Product code
OWO
Generic name
Drug-eluting sinus stent
Decision date
2014-02-11
Decision code
OK30
Date received
2014-01-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE SUPPLIER BE CLEARED.