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PreveLeak Surgical Sealant & 10pk applictor tips

FDA premarket approval P100030/S005 · decided 2017-05-19

Approval details

PMA number
P100030
Supplement
S005
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PreveLeak Surgical Sealant & 10pk applictor tips
Generic name
Sealant, polymerizing
Applicant
Baxter Healthcare Corporation
Date received
2016-07-26
Decision date
2017-05-19
Days to decision
297 days
Decision code
APPR
Product code
NBE
Advisory committee
Cardiovascular
Expedited review
No
Location
Deerfield Lake, IL
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.

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