PMA P910077S173
- Device
- LATITUDE Programming System, Brady v1.06 with Heart Connect
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S173
- Product code
- LWS
- Decision date
- 2019-10-18
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval to modify the Model 3300 LATITUDE Programming System software components to update the Brady device application code base, add support for 4G cellular communications, and add an integrated Heart Connect application.
Current openFDA PMA Record#
- Device
- LATITUDE Programming System, Brady v1.06 with Heart Connect
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S173
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-10-18
- Decision code
- APPR
- Date received
- 2019-07-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to modify the Model 3300 LATITUDE Programming System software components to update the Brady device application code base, add support for 4G cellular communications, and add an integrated Heart Connect application.