PMA P070008S042
- Device
- CELERITY,COROX
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S042
- Product code
- NKE
- Decision date
- 2013-05-17
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- USE A NEW MAXIMUM STERILIZATION CHAMBER LOAD AT THE CONTRACT STERILIZER FOR THEIR MARKETED LEADS.
Current openFDA PMA Record#
- Device
- CELERITY,COROX
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S042
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2013-05-17
- Decision code
- OK30
- Date received
- 2013-04-22
- Supplement type
- 30-Day Notice
- Approval order statement
- USE A NEW MAXIMUM STERILIZATION CHAMBER LOAD AT THE CONTRACT STERILIZER FOR THEIR MARKETED LEADS.