PMA P950024S100

Device
CapSure Epicardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P950024
Supplement
S100
Product code
NVN
Decision date
2021-10-19
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
Remove air-drying time at Final Wash Operation of a CapSure Epicardial Pacing Lead model 4968.

Current openFDA PMA Record#

Device
CapSure Epicardial Pacing Lead
Applicant
Medtronic, Inc.
PMA number
P950024
Supplement
S100
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2021-10-19
Decision code
OK30
Date received
2021-10-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Remove air-drying time at Final Wash Operation of a CapSure Epicardial Pacing Lead model 4968.