PMA P960040S515
- Device
- Tachy Pulse Generators
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S515
- Product code
- LWS
- Decision date
- 2026-08-25
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- approval for the SMR16 software maintenance release to update the NG4 pulse generator firmware and Model 3868 Tachy programmer software application
Current openFDA PMA Record#
- Device
- Tachy Pulse Generators
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S515
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-08-25
- Decision code
- APPR
- Date received
- 2026-06-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the SMR16 software maintenance release to update the NG4 pulse generator firmware and Model 3868 Tachy programmer software application