Last synced on 21 February 2025 at 11:05 pm

Barrier, Adhesion, Cardiovascular

Page Type
Product Code
Definition
Indicated to reduce the incidence, severity or extent of adhesions/tissue attachment in cardiovascular surgery by providing a plane of dissection or mechanical barrier between opposing surfaces of tissue and/or devices. Intended for use in cardiac surgery to prevent or reduce adhesions, and facilitate reoperation in patients who are anticipated to need staged cardiovascular surgeries or repeat procedures in the thoracic region.
Physical State
a resorbable synthetic polymeric material that is either a sheet of material or a spray liquid
Technical Method
the barrier may be either placed in the area of concern, or sutured in place, or sprayed onto the area
Target Area
thoracic region
Review Panel
Cardiovascular
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
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 OBD 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.

Barrier, Adhesion, Cardiovascular

Page Type
Product Code
Definition
Indicated to reduce the incidence, severity or extent of adhesions/tissue attachment in cardiovascular surgery by providing a plane of dissection or mechanical barrier between opposing surfaces of tissue and/or devices. Intended for use in cardiac surgery to prevent or reduce adhesions, and facilitate reoperation in patients who are anticipated to need staged cardiovascular surgeries or repeat procedures in the thoracic region.
Physical State
a resorbable synthetic polymeric material that is either a sheet of material or a spray liquid
Technical Method
the barrier may be either placed in the area of concern, or sutured in place, or sprayed onto the area
Target Area
thoracic region
Review Panel
Cardiovascular
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
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 OBD 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.