Adherus AutoSpray ET Dural Sealant
FDA premarket approval P130014/S012 · decided 2021-09-15
Approval details
- PMA number
- P130014
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Adherus AutoSpray ET Dural Sealant
- Generic name
- Sealant, dural
- Applicant
- Stryker Leibinger GmbH & Co KG
- Date received
- 2021-08-24
- Decision date
- 2021-09-15
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Freiburg
- Statement
- Alternate supplier to supply ET parts for the delivery system of Adherus AutoSpray ET Dural Sealant.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.