PMA P930039S226
- Device
- CapSureFix Novus Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P930039
- Supplement
- S226
- Product code
- NVN
- Decision date
- 2021-05-26
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Addition of removal process for Loose foreign material/adhesive on helix electrodes.
Current openFDA PMA Record#
- Device
- CapSureFix Novus Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P930039
- Supplement
- S226
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2021-05-26
- Decision code
- OK30
- Date received
- 2021-04-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of removal process for Loose foreign material/adhesive on helix electrodes.