GUARDIAN RT
FDA premarket approval P980022/S014 · decided 2006-12-27
Approval details
- PMA number
- P980022
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- GUARDIAN RT
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2005-12-27
- Decision date
- 2006-12-27
- Days to decision
- 365 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY.
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