PMA P930039S156
- Device
- CapSure Fix Novus Lead; Vitatron Crystalline Active; Fixation Lead, ICF09, ICQ09B
- Applicant
- Medtronic, Inc.
- PMA number
- P930039
- Supplement
- S156
- Product code
- NVN
- Decision date
- 2016-09-20
- 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
- Updates to pull test sample sizes and control limits.
Current openFDA PMA Record#
- Device
- CapSure Fix Novus Lead; Vitatron Crystalline Active; Fixation Lead, ICF09, ICQ09B
- Applicant
- Medtronic, Inc.
- PMA number
- P930039
- Supplement
- S156
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2016-09-20
- Decision code
- OK30
- Date received
- 2016-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to pull test sample sizes and control limits.