Atlas FDA

WATCHMAN Left Atrial Appendage Closure Device

FDA premarket approval P130013/S033 · decided 2019-10-18

Approval details

PMA number
P130013
Supplement
S033
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
WATCHMAN Left Atrial Appendage Closure Device
Generic name
System, appendage closure, left atrial
Applicant
Boston Scientific Corp
Date received
2019-07-23
Decision date
2019-10-18
Days to decision
87 days
Decision code
APPR
Product code
NGV
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Approval to update the clinical data in the directions for use with the currently available data and make minor changes to the language in the directions for use and patient brochure.

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510(k) clearances by this applicant

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WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21