PMA P950024S087
- Device
- Capsure Epicardial Pacing Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P950024
- Supplement
- S087
- Product code
- NVN
- Decision date
- 2019-07-22
- Classification
- Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Update the incoming inspection and component specification for TiO2 pigment paste.
Current openFDA PMA Record#
- Device
- Capsure Epicardial Pacing Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P950024
- Supplement
- S087
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2019-07-22
- Decision code
- OK30
- Date received
- 2019-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the incoming inspection and component specification for TiO2 pigment paste.