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PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE

FDA premarket approval N970003/S298 · decided 2024-12-18

Approval details

PMA number
N970003
Supplement
S298
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2024-11-19
Decision date
2024-12-18
Days to decision
29 days
Decision code
OK30
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
to add functionally equivalent battery handler automation system, associated functionally equivalent test system and test software

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