PMA P100044S016

Device: PROPEL SINUS IMPLANT AND PROPEL MINI SINUS IMPLANT
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S016
Product code: OWO
Decision date: 2014-05-23
Classification: Drug-eluting Sinus Stent
Generic name: Drug-eluting sinus stent
Approval order statement: ADDITION OF A NEW POUCH SEALING EQUIPMENT, SENCORP WHITE HEAT SEALER WITH VACCUUM AND GAS PURGE MODEL 12-PV/2, TO THE EXISTING MANUFACTURING LINE FOR THE PACKAGING OF THE PROPEL AND PROPEL MINI SINUS IMPLANTS.

Current openFDA PMA Record#

Device: PROPEL SINUS IMPLANT AND PROPEL MINI SINUS IMPLANT
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S016
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2014-05-23
Decision code: OK30
Date received: 2014-04-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A NEW POUCH SEALING EQUIPMENT, SENCORP WHITE HEAT SEALER WITH VACCUUM AND GAS PURGE MODEL 12-PV/2, TO THE EXISTING MANUFACTURING LINE FOR THE PACKAGING OF THE PROPEL AND PROPEL MINI SINUS IMPLANTS.