PMA P960006S058

Device: Fixation Tool Model 6616
Applicant: Boston Scientific
PMA number: P960006
Supplement: S058
Product code: NVN
Decision date: 2026-04-10
Classification: Cardiovascular
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: approval for minor labeling changes, removal of paper IFU, and minor dimensional changes to sterile pouches

Current openFDA PMA Record#

Device: Fixation Tool Model 6616
Applicant: Boston Scientific
PMA number: P960006
Supplement: S058
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2026-04-10
Decision code: APPR
Date received: 2026-02-04
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for minor labeling changes, removal of paper IFU, and minor dimensional changes to sterile pouches