PMA P070008S049
- Device
- STRATOS, EVIA, & ENTOVIS FAMILIES OF CRT-P'S
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S049
- Product code
- NKE
- Decision date
- 2014-06-20
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- APPROVAL FOR PSW 1306.U PROGRAMMER SOFTWARE.
Current openFDA PMA Record#
- Device
- STRATOS, EVIA, & ENTOVIS FAMILIES OF CRT-P'S
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S049
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2014-06-20
- Decision code
- APPR
- Date received
- 2013-11-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR PSW 1306.U PROGRAMMER SOFTWARE.