PMA P100044S020

Device: PROPEL
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S020
Product code: OWO
Decision date: 2016-08-24
Classification: Drug-eluting Sinus Stent
Generic name: Drug-eluting sinus stent
Approval order statement: Approval for a manufacturing site located at Synergy Health AST, LLC, Lakevillle Hwy, Suite 120, Petaluma, CA 94954 as a backup sterilization facility for the Propel and Propel Mini Sinus Implants.

Current openFDA PMA Record#

Device: PROPEL
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S020
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2016-08-24
Decision code: APPR
Date received: 2016-03-25
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, LLC, Lakevillle Hwy, Suite 120, Petaluma, CA 94954 as a backup sterilization facility for the Propel and Propel Mini Sinus Implants.