PMA P070008S051
- Device
- VARIOUS MODELS OF COROX, CELERITY AND LV LEADS
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S051
- Product code
- NKE
- Decision date
- 2014-06-30
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- COROX, CELERITY LEADS
Current openFDA PMA Record#
- Device
- VARIOUS MODELS OF COROX, CELERITY AND LV LEADS
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S051
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2014-06-30
- Decision code
- OK30
- Date received
- 2014-05-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- COROX, CELERITY LEADS