PMA P980023S057
- Device
- PROTEGO FAMILY OF ICD LEADS
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S057
- Product code
- NVY
- Decision date
- 2014-07-03
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- APPROVAL FOR THE DF4 VARIANTS OF THE CURRENTLY APPROVED ILESTO/IFORIAICDS/CRT-DS AND LINOXSMART ICD LEADS.
Current openFDA PMA Record#
- Device
- PROTEGO FAMILY OF ICD LEADS
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S057
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2014-07-03
- Decision code
- APPR
- Date received
- 2014-01-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE DF4 VARIANTS OF THE CURRENTLY APPROVED ILESTO/IFORIAICDS/CRT-DS AND LINOXSMART ICD LEADS.