PMA P150012S177
- Device
- INGEVITY™ Family Bradycardia Leads
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S177
- Product code
- LWP
- Decision date
- 2026-01-09
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- to implement a controlled rework process for bradycardia leads
Current openFDA PMA Record#
- Device
- INGEVITY™ Family Bradycardia Leads
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S177
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2026-01-09
- Decision code
- OK30
- Date received
- 2025-12-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement a controlled rework process for bradycardia leads