BRIO LE CHARGING SYSTEM
FDA premarket approval P140009/S005 · decided 2015-12-18
Approval details
- PMA number
- P140009
- Supplement
- S005
- Supplement type
- Real-Time Process
- Trade name
- BRIO LE CHARGING SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-09-21
- Decision date
- 2015-12-18
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEXICO, TIJUANA, BAJA CALIFORNIA, MEXICO.
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