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ADEPT Adhesion Reduction Solution

FDA premarket approval P050011/S006 · decided 2019-06-03

Approval details

PMA number
P050011
Supplement
S006
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
ADEPT Adhesion Reduction Solution
Generic name
Barrier, absorbable, adhesion
Applicant
Baxter Healthcare Corp
Date received
2017-05-17
Decision date
2019-06-03
Days to decision
747 days
Decision code
APPR
Product code
MCN
Advisory committee
Obstetrics/Gynecology
Expedited review
No
Location
Mcgaw Park, IL
Statement
Approval for a transfer of the design-owning organization from Baxter AG Vienna, Austria to Baxter Alliance Park Braine-L'Alleud, Belgium and final release testing and product release functions from Baxter AG Vienna, Austria to Baxter Castlebar, Ireland for the ADEPT Adhesion Reduction Solution.

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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