Atlas FDA

9767/9767L PROGRAMMING HEAD AND MODEL9990 DESKTOP SOFTWARE

FDA premarket approval P890003/S063 · decided 2001-05-07

Approval details

PMA number
P890003
Supplement
S063
Supplement type
Normal 180 Day Track
Trade name
9767/9767L PROGRAMMING HEAD AND MODEL9990 DESKTOP SOFTWARE
Generic name
implantable pacemaker Pulse-generator
Applicant
Medtronic, Inc.
Date received
2001-04-11
Decision date
2001-05-07
Days to decision
26 days
Decision code
APPR
Product code
DXY
Advisory committee
Cardiovascular
Expedited review
No
Location
Mounds View, MN
Statement
APPROVAL FOR THE MEDTRONIC MODEL 9767/9767L PROGRAMMING HEAD AND MODEL 9990 DESKTOP SOFTWARE.

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