PMA P910077S151
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S151
- Product code
- OSR
- Decision date
- 2016-02-05
- Classification
- Pacemaker/icd/crt Non-implanted Components
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- Approval for software changes to the patient management system.
Current openFDA PMA Record#
- Device
- LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S151
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2016-02-05
- Decision code
- APPR
- Date received
- 2015-12-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software changes to the patient management system.