PMA P930039S232
- Device
- CapSureFix Novus Lead Models 4076 and 5076
- Applicant
- Medtronic, Inc.
- PMA number
- P930039
- Supplement
- S232
- Product code
- NVN
- Decision date
- 2021-10-01
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Modifications to the backfill/bonding processes for CapSureFix Novus leads.
Current openFDA PMA Record#
- Device
- CapSureFix Novus Lead Models 4076 and 5076
- Applicant
- Medtronic, Inc.
- PMA number
- P930039
- Supplement
- S232
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2021-10-01
- Decision code
- OK30
- Date received
- 2021-09-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the backfill/bonding processes for CapSureFix Novus leads.