Atlas FDA

FLOSEAL HEMOSTATIC MATRIX

FDA premarket approval P990009/S042 · decided 2016-11-22

Approval details

PMA number
P990009
Supplement
S042
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
FLOSEAL HEMOSTATIC MATRIX
Generic name
Absorbable collagen hemostatic agent with thrombin
Applicant
Baxter Healthcare Corp
Date received
2016-06-02
Decision date
2016-11-22
Days to decision
173 days
Decision code
APPR
Product code
PMX
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Round Lake, IL
Statement
Approval for artwork changes to the exterior of the product syringes, removal of a colorant clarifier from the syringe plunger, and addition of a black colorant to the plunger tip of the mixing syringe in order to support the addition of an alternative syringe supplier.

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510(k) clearances by this applicant

RecordFirmDate
PrisMax System Version 2 (K190910)Baxter Healthcare Corp2019-07-25
PrisMax Control Unit (K163530)Baxter Healthcare Corp2017-05-03
ULTRAFUSE (K130531)Baxter Healthcare Corp2014-04-08
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS (K132734)Baxter Healthcare Corp2013-10-08
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO (K130245)Baxter Healthcare Corp2013-03-01
INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S (K123874)Baxter Healthcare Corp2013-01-10
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET (K123868)Baxter Healthcare Corp2013-01-08
FLOWEASE [SUBCUTANEOUS] INFUSION SET (K121092)Baxter Healthcare Corp2012-06-29