PMA P960006S057

Device: ACC SUP FIXATION TOOL
Applicant: Boston Scientific
PMA number: P960006
Supplement: S057
Product code: NVN
Decision date: 2025-09-16
Classification: Cardiovascular
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: for removing an Ethelyne Oxide (EO) chemical indicator dot applied to the outside of sterile packaging pre-sterilization and evaluated visually post-sterilization

Current openFDA PMA Record#

Device: ACC SUP FIXATION TOOL
Applicant: Boston Scientific
PMA number: P960006
Supplement: S057
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2025-09-16
Decision code: OK30
Date received: 2025-09-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for removing an Ethelyne Oxide (EO) chemical indicator dot applied to the outside of sterile packaging pre-sterilization and evaluated visually post-sterilization