PMA P070008S023
- Device
- STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S023
- Product code
- NKE
- Decision date
- 2011-05-26
- 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 AN ADDITIONAL SUPPLIER FOR A SECOND SOURCE OF SILICONES FOR USE IN INJECTION MOLDED PARTS FOR LEADS AND ACCESSORIES, AND SEALING PLUGS IN PGS AND ICDS.
Current openFDA PMA Record#
- Device
- STRATOS LV/LV-T/COROX OTW (-S) BP/COROX OTW-L BP
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S023
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2011-05-26
- Decision code
- APPR
- Date received
- 2011-04-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ADDITIONAL SUPPLIER FOR A SECOND SOURCE OF SILICONES FOR USE IN INJECTION MOLDED PARTS FOR LEADS AND ACCESSORIES, AND SEALING PLUGS IN PGS AND ICDS.