Barricaid Anular Closure Device (ACD)
FDA premarket approval P160050/S003 · decided 2020-03-17
Approval details
- PMA number
- P160050
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Barricaid Anular Closure Device (ACD)
- Generic name
- Reherniation reduction device
- Applicant
- Intrinsic Therapeutics
- Date received
- 2019-03-19
- Decision date
- 2020-03-17
- Days to decision
- 364 days
- Decision code
- APPR
- Product code
- QES
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Woburn, MA
- 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).
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