PMA P010012S387
- Device
- COGNIS,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S387
- Product code
- OSR
- Decision date
- 2015-07-21
- Classification
- Pacemaker/icd/crt Non-implanted Components
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- APPROVAL FOR SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).
Current openFDA PMA Record#
- Device
- COGNIS,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S387
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2015-07-21
- Decision code
- APPR
- Date received
- 2015-04-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE UPDATES TO THE LATITUDE NXT PATIENT MANAGEMENT SYSTEM (RELEASE 4.0).