FDA.reportPublic FDA data

PMA P960030S076

Device
IsoFlex
Applicant
ABBOTT MEDICAL
PMA number
P960030
Supplement
S076
Product code
NVN
Decision date
2022-08-01
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
Implementation of the automated system Vaisala EMS system for environmental and process equipment monitoring at the Rogers, Minnesota manufacturing site.

Current openFDA PMA Record#

Device
IsoFlex
Applicant
ABBOTT MEDICAL
PMA number
P960030
Supplement
S076
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2022-08-01
Decision code
OK30
Date received
2022-07-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of the automated system Vaisala EMS system for environmental and process equipment monitoring at the Rogers, Minnesota manufacturing site.