PMA P100044S019

Device: PROPEL AND PROPEL MINI SINUS IMPLANTS
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S019
Product code: OWO
Decision date: 2015-10-28
Classification: Drug-eluting Sinus Stent
Generic name: Drug-eluting sinus stent
Approval order statement: ADDING AN INCOMING QUALITY ASSURANCE TEST FOR SHRINKAGE OF THE FIBER COMPONENTS OF THE PROPEL AND PROPEL MINI PRODUCTS AND TO INCREASE THE UPPER LIMIT FOR THE INHERENT VISCOSITY (IV) MANUFACTURING LOT RELEASE SPECIFICATION TO MATCH THE UPPER LIMIT FOR THE CURRENT IV DESIGN SPECIFICATION.

Current openFDA PMA Record#

Device: PROPEL AND PROPEL MINI SINUS IMPLANTS
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S019
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2015-10-28
Decision code: OK30
Date received: 2015-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDING AN INCOMING QUALITY ASSURANCE TEST FOR SHRINKAGE OF THE FIBER COMPONENTS OF THE PROPEL AND PROPEL MINI PRODUCTS AND TO INCREASE THE UPPER LIMIT FOR THE INHERENT VISCOSITY (IV) MANUFACTURING LOT RELEASE SPECIFICATION TO MATCH THE UPPER LIMIT FOR THE CURRENT IV DESIGN SPECIFICATION.