PMA P160050S002
- Device
- Barricaid Anular Closure Device
- Applicant
- Intrinsic Therapeutics
- PMA number
- P160050
- Supplement
- S002
- Product code
- QES
- Decision date
- 2019-05-03
- Classification
- Reherniation Reduction Device
- Generic name
- Reherniation reduction device
- Approval order statement
- Approval for the addition of a manufacturing site for manual lapping and the addition of an automated lapping step.
Current openFDA PMA Record#
- Device
- Barricaid Anular Closure Device
- Applicant
- Intrinsic Therapeutics
- PMA number
- P160050
- Supplement
- S002
- Product code
- QES
- Generic name
- Reherniation reduction device
- Decision date
- 2019-05-03
- Decision code
- APPR
- Date received
- 2019-03-11
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of a manufacturing site for manual lapping and the addition of an automated lapping step.