PMA P150012S181

Device: • Lead Stylets, Straight, X-Soft Models 5003, 5004, 5005 • Lead Stylets, Long Tapered, Soft Models 5012, 5013, 5014
Applicant: Boston Scientific
PMA number: P150012
Supplement: S181
Product code: LWP
Decision date: 2026-04-10
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: approval for minor labeling changes, removal of paper IFU, and minor dimensional changes to sterile pouches

Current openFDA PMA Record#

Device: • Lead Stylets, Straight, X-Soft Models 5003, 5004, 5005 • Lead Stylets, Long Tapered, Soft Models 5012, 5013, 5014
Applicant: Boston Scientific
PMA number: P150012
Supplement: S181
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
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