PMA P100030S005

Device: PreveLeak Surgical Sealant & 10pk applictor tips
Applicant: Baxter Healthcare Corporation
PMA number: P100030
Supplement: S005
Product code: NBE
Decision date: 2017-05-19
Classification: Sealant, Polymerizing
Generic name: Sealant, polymerizing
Approval order statement: Approval for manufacturing sites located at Synergy Health AST, LLC, 9020 Activity Road Suite D, San Diego, California 92126 and Synergy Health AST, LLC, 3200 Lakeville Highway, Suite 120, Petaluma, California 94954, for sterilization of the PreveLeak Syringes and Applicator Tips.

Current openFDA PMA Record#

Device: PreveLeak Surgical Sealant & 10pk applictor tips
Applicant: Baxter Healthcare Corporation
PMA number: P100030
Supplement: S005
Product code: NBE
Generic name: Sealant, polymerizing
Decision date: 2017-05-19
Decision code: APPR
Date received: 2016-07-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for manufacturing sites located at Synergy Health AST, LLC, 9020 Activity Road Suite D, San Diego, California 92126 and Synergy Health AST, LLC, 3200 Lakeville Highway, Suite 120, Petaluma, California 94954, for sterilization of the PreveLeak Syringes and Applicator Tips.