ATTAIN STARFIX LEAD
FDA premarket approval P060039/S059 · decided 2014-09-04
Approval details
- PMA number
- P060039
- Supplement
- S059
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATTAIN STARFIX LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2014-06-26
- Decision date
- 2014-09-04
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR UPDATES TO THE FINISHED PRODUCT RELEASE CRITERIA FOR CONTENT UNIFORMITY AND ELUTION FOR THE ATTAIN STARFIX MODEL 4195 LEAD.
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