PMA P930039S119
- Device
- SUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P930039
- Supplement
- S119
- Product code
- NVY
- Decision date
- 2014-10-14
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- OUTSOURCE THE SUPPLY OF THREE MOLDED COMPONENTS USED IN THE MANUFACTURE OF THE LEAD MODELS.
Current openFDA PMA Record#
- Device
- SUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P930039
- Supplement
- S119
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2014-10-14
- Decision code
- OK30
- Date received
- 2014-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- OUTSOURCE THE SUPPLY OF THREE MOLDED COMPONENTS USED IN THE MANUFACTURE OF THE LEAD MODELS.