Atlas FDA

WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE

FDA premarket approval P130013/S009 · decided 2016-08-04

Approval details

PMA number
P130013
Supplement
S009
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE
Generic name
System, appendage closure, left atrial
Applicant
Boston Scientific Corp
Date received
2016-05-19
Decision date
2016-08-04
Days to decision
77 days
Decision code
APPR
Product code
NGV
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Approval for a manufacturing site located at Boston Scientific Corporation, Maple Grove Facility located at One Scimed Place, Maple Grove, Minnesota, 55311 as an additional manufacturing site for the Watchman Closure Device with Delivery System.

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