Last synced on 19 April 2024 at 11:05 pm

Tympanostomy Tube Delivery Product With Drug

Page Type
Product Code
Definition
Intended to place a tympanostomy tube across the tympanic membrane under local anesthesia.
Physical State
This product is comprised of a tympanostomy tube, tympanostomy tube delivery system, anesthesia drug, and an iontophoretic local anesthesia delivery system. This product includes a mechanical device that rapidly creates a myringotomy and places the tympanostomy tube across the tympanic membrane after the anesthetic drug numbs the tympanic membrane.
Technical Method
A local anesthetic system delivers anesthetic drug and electric current to provide sufficient anesthesia to place a tympanostomy tube. A tympanostomy tube delivery device is then used to rapidly place the tympanostomy tube across the tympanic membrane.
Target Area
Tympanic membrane
Review Panel
Ear, Nose, Throat
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code QJA to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.

Tympanostomy Tube Delivery Product With Drug

Page Type
Product Code
Definition
Intended to place a tympanostomy tube across the tympanic membrane under local anesthesia.
Physical State
This product is comprised of a tympanostomy tube, tympanostomy tube delivery system, anesthesia drug, and an iontophoretic local anesthesia delivery system. This product includes a mechanical device that rapidly creates a myringotomy and places the tympanostomy tube across the tympanic membrane after the anesthetic drug numbs the tympanic membrane.
Technical Method
A local anesthetic system delivers anesthetic drug and electric current to provide sufficient anesthesia to place a tympanostomy tube. A tympanostomy tube delivery device is then used to rapidly place the tympanostomy tube across the tympanic membrane.
Target Area
Tympanic membrane
Review Panel
Ear, Nose, Throat
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code QJA to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.