PMA P950024S116
- Device
- CapSure Epicardial Pacing Lead (4965); CapSure Epicardial Pacing Lead (4968)
- Applicant
- Medtronic, Inc.
- PMA number
- P950024
- Supplement
- S116
- Product code
- NVN
- Decision date
- 2026-02-10
- Classification
- Cardiovascular
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- a new vapor degreasing solvent
Current openFDA PMA Record#
- Device
- CapSure Epicardial Pacing Lead (4965); CapSure Epicardial Pacing Lead (4968)
- Applicant
- Medtronic, Inc.
- PMA number
- P950024
- Supplement
- S116
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2026-02-10
- Decision code
- OK30
- Date received
- 2026-01-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new vapor degreasing solvent