Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device drug-eluting sinus stent
Definition Mechanically maintain patency following ethmoid sinus surgery. By also eluting drugs, reduce the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.
Product CodeOWO
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
1 3 0 4 3 1

MDR Year MDR Reports MDR Events
2021 1 1
2023 1 1
2024 2 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 3 3
Unspecified Infection 2 2
Impaired Healing 2 2
Sinusitis 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Implant Pain 1 1
Purulent Discharge 1 1
Burning Sensation 1 1
Insufficient Information 1 1
Chemosis 1 1
Blurred Vision 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Intersect ENT, Inc. II Dec-08-2022
-
-