Atlas FDA

INSYNC ICD MODEL 7272

FDA premarket approval P010031/S294 · decided 2012-03-23

Approval details

PMA number
P010031
Supplement
S294
Supplement type
30-Day Notice
Trade name
INSYNC ICD MODEL 7272
Applicant
Medtronic Cardiac Rhythm Disease Management
Date received
2012-02-29
Decision date
2012-03-23
Days to decision
23 days
Decision code
OK30
Advisory committee
Cardiovascular
Expedited review
No
Location
Mounds View, MN
Statement
UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.

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