PMA P160050S001
- Device
- Barricaid Anular Closure Device
- Applicant
- Intrinsic Therapeutics
- PMA number
- P160050
- Supplement
- S001
- Product code
- QES
- Decision date
- 2019-05-07
- Classification
- Reherniation Reduction Device
- Generic name
- Reherniation reduction device
- Approval order statement
- Approval of two protocols for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Barricaid Anular Closure Device
- Applicant
- Intrinsic Therapeutics
- PMA number
- P160050
- Supplement
- S001
- Product code
- QES
- Generic name
- Reherniation reduction device
- Decision date
- 2019-05-07
- Decision code
- APPR
- Date received
- 2019-03-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of two protocols for the post-approval study (PAS) protocol.