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ACUITY X4 Straight, Models 4671 and 4672; ACUITY X4 Spiral S, Models 4674 and 4675; ACUITY X4 Spiral L, Models 4677 and

FDA premarket approval P010012/S591 · decided 2025-09-03

Approval details

PMA number
P010012
Supplement
S591
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ACUITY X4 Straight, Models 4671 and 4672; ACUITY X4 Spiral S, Models 4674 and 4675; ACUITY X4 Spiral L, Models 4677 and
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Applicant
Boston Scientific Corp
Date received
2025-06-05
Decision date
2025-09-03
Days to decision
90 days
Decision code
APPR
Product code
NIK
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
approval for a change to a raw material and supplier for the tubing used in ACUITY X4 leads, as well as associated manufacturing changes

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