Adherus AutoSpray Dural and ET Dural Sealant
FDA premarket approval P130014/S005 · decided 2018-07-31
Approval details
- PMA number
- P130014
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Adherus AutoSpray Dural and ET Dural Sealant
- Generic name
- Sealant, dural
- Applicant
- Stryker Leibinger GmbH & Co KG
- Date received
- 2018-02-12
- Decision date
- 2018-07-31
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- NQR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Freiburg
- Statement
- Approval for manufacturing sites located at STERIS Applied Sterilization Technologies (AST) dba Synergy Health AST, LLC, 7225 North Noah Drive, Saxonburg, Pennsylvania 16056 and STERIS Applied Sterilization Technologies (AST) dba Synergy Health AST, LLC, 3200 Lakeville Hwy, Suite 120, Petaluma, California 94954, as contract sterilizers.
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