- Device
- Barricaid Anular Closure Device (ACD)
- Applicant
- Intrinsic Therapeutics
- PMA number
- P160050
- Supplement
- S003
- Product code
- QES
- Generic name
- Reherniation reduction device
- Decision date
- 2020-03-17
- Decision code
- APPR
- Date received
- 2019-03-19
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to change the supplier and specifications of the polyester yarn used to make the mesh of the woven fabric for the flexible occlusion component of the Barricaid Anular Closure Device (ACD).