FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Tympanostomy Tube Delivery Product With Drug
PMA: P190016
·
Supplement: S005
·
Decision Sep 22, 2022
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Tympanostomy Tube Delivery Product With Drug
- Trade Name
- Tula® System
- PMA Number
- P190016
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- QJA
- Generic Name
- Tympanostomy tube delivery product with drug
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- September 22, 2022
- Date Received
- August 24, 2022
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Modification to the adhesive application process for the earplug.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QJA | Tympanostomy Tube Delivery Product With Drug | FDA class 3 | Unknown |