PMA P980023S013
- Device
- KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S013
- Product code
- DTA
- Decision date
- 2003-07-29
- Classification
- Tester, Pacemaker Electrode Function
- Generic name
- TESTER, PACEMAKER ELECTRODE FUNCTION
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S013
- Product code
- DTA
- Generic name
- TESTER, PACEMAKER ELECTRODE FUNCTION
- Decision date
- 2003-07-29
- Decision code
- APPR
- Date received
- 2003-02-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.