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PMA P950024S091

Device
CapSure Epicardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P950024
Supplement
S091
Product code
NVN
Decision date
2020-03-06
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
Transfer two incoming inspection activities for device components from Medtronic Rice Creek to Medtronic Puerto Rico Operations Company Villalba/Juncos sites.

Current openFDA PMA Record#

Device
CapSure Epicardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P950024
Supplement
S091
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2020-03-06
Decision code
OK30
Date received
2020-02-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Transfer two incoming inspection activities for device components from Medtronic Rice Creek to Medtronic Puerto Rico Operations Company Villalba/Juncos sites.