CAPSUREFIX NOVUS LEAD AND VITATRON CRYSTALLINE ACTIVE FIXATION LEAD
FDA premarket approval P930039/S122 · decided 2015-01-06
Approval details
- PMA number
- P930039
- Supplement
- S122
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSUREFIX NOVUS LEAD AND VITATRON CRYSTALLINE ACTIVE FIXATION LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2014-12-08
- Decision date
- 2015-01-06
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATES TO THE PARAMETERS OF THE PLASMA TREATMENT PROCESS USED FOR THE SILICONE TUBING COMPONENT.
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