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PMA P960004S115

Device
Stylet (Models 6033, 6034, 6036, 6037, 6039, 6040, 6042, 6043, 6053, 6054, 6055, 6058, 6059, 6062, 6063, 6064, 6065, 606
Applicant
Boston Scientific
PMA number
P960004
Supplement
S115
Product code
NVN
Decision date
2026-05-15
Classification
Cardiovascular
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
to change sites for ethylene oxide (EO) gas sterilization operations and final packaging activities for the Accessories used with the Cardiac Rhythm Management (CRM) division’s Pulse Generators and Leads.

Current openFDA PMA Record#

Device
Stylet (Models 6033, 6034, 6036, 6037, 6039, 6040, 6042, 6043, 6053, 6054, 6055, 6058, 6059, 6062, 6063, 6064, 6065, 606
Applicant
Boston Scientific
PMA number
P960004
Supplement
S115
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2026-05-15
Decision code
OK30
Date received
2026-04-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to change sites for ethylene oxide (EO) gas sterilization operations and final packaging activities for the Accessories used with the Cardiac Rhythm Management (CRM) division’s Pulse Generators and Leads.