PMA P160050S008
- Device
- Barricaid® Annular Closure Device
- Applicant
- Intrinsic Therapeutics
- PMA number
- P160050
- Supplement
- S008
- Product code
- QES
- Decision date
- 2024-02-08
- Classification
- Orthopedic
- Generic name
- Reherniation reduction device
- Approval order statement
- a change to the material supplier for the nonabsorbable surgical suture sub-component used to assemble the polymer mesh component of the final device
Current openFDA PMA Record#
- Device
- Barricaid® Annular Closure Device
- Applicant
- Intrinsic Therapeutics
- PMA number
- P160050
- Supplement
- S008
- Product code
- QES
- Generic name
- Reherniation reduction device
- Decision date
- 2024-02-08
- Decision code
- OK30
- Date received
- 2024-01-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the material supplier for the nonabsorbable surgical suture sub-component used to assemble the polymer mesh component of the final device