ATTAIN STARFIX
FDA premarket approval P060039/S023 · decided 2011-06-16
Approval details
- PMA number
- P060039
- Supplement
- S023
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ATTAIN STARFIX
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2011-03-18
- Decision date
- 2011-06-16
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE STERILE BARRIER TRAYS AND CHANGE IN ORIENTATION OF TOOLING ID NUMBER ON THE TRAY.
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510(k) clearances by this applicant
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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