MODEL 4195 ATTAIN STARFIX LEAD
FDA premarket approval P060039/S021 · decided 2011-11-22
Approval details
- PMA number
- P060039
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 4195 ATTAIN STARFIX LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2011-01-26
- Decision date
- 2011-11-22
- Days to decision
- 300 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE IN THE REQUIREMENT FOR THE COPPER CONTENT IN THE BLUE POLYURETHANE TUBING UTILIZED BY THE MEDTRONIC ATTAIN STARFIX LEAD FROM 200 PPM TO 300 PPM.
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