|
Device | PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT |
Generic Name | Drug-eluting sinus stent |
Applicant | INTERSECT ENT 1555 ADAMS DR MENLO PARK, CA 94025 |
PMA Number | P100044 |
Supplement Number | S010 |
Date Received | 06/25/2013 |
Decision Date | 08/13/2013 |
Product Code |
OWO |
Advisory Committee |
Ear Nose & Throat |
Clinical Trials | NCT00840970
|
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
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. |