PMA N970003

Device
PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE
Applicant
Boston Scientific Corp
PMA number
N970003
Supplement
S282
Product code
LWP
Decision date
2026-04-01
Generic name
Implantable pulse generator, pacemaker (non-CRT)

Current openFDA PMA Record#

Device
PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE
Applicant
Boston Scientific Corp
PMA number
N970003
Supplement
S306
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2026-04-01
Decision code
OK30
Date received
2026-03-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier