PMA P950024S101
- Device
- CapSure Epicardial Pacing Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P950024
- Supplement
- S101
- Product code
- NVN
- Decision date
- 2021-12-07
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Update the manufacturing execution system (MES) to FACTORYworks (FW) Release 9.9.
Current openFDA PMA Record#
- Device
- CapSure Epicardial Pacing Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P950024
- Supplement
- S101
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2021-12-07
- Decision code
- OK30
- Date received
- 2021-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the manufacturing execution system (MES) to FACTORYworks (FW) Release 9.9.