PMA P100044S010

Device: PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S010
Product code: OWO
Decision date: 2013-08-13
Classification: Drug-eluting Sinus Stent
Generic name: Drug-eluting sinus stent
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE (IFU) AND LABELS THAT ENHANCE THE SAFETY IN THE USE OF THE PROPEL AND PROPEL MINI SINUS IMPLANTS.

Current openFDA PMA Record#

Device: PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S010
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2013-08-13
Decision code: APPR
Date received: 2013-06-25
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE (IFU) AND LABELS THAT ENHANCE THE SAFETY IN THE USE OF THE PROPEL AND PROPEL MINI SINUS IMPLANTS.