Company
United StatesMedtronic Advanced Energy LLC, Palo Alto, CA – FDA Inspections
Inspection records and compliance data for Medtronic Advanced Energy LLC in Palo Alto, California. 3 FDA inspections on record, last inspected July 03, 2012.
Company Profile
This profile covers Medtronic Advanced Energy LLC based in Palo Alto, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected July 6, 2009. Last inspected July 3, 2012.
Most cited issue areas
- Individual Report of Malfunction2 inspections
- Lack of or inadequate complaint procedures2 inspections
- Design input - documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 3, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 789244 |
| August 18, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 677087 |
| July 6, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 597742 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Medtronic Advanced Energy LLC
FEI Number
3007069406
Address
2464 Embarcadero Way, Palo Alto, California 94303, United States
Country
United States
ID: 6cd664a0-9c4c-4481-afb5-8b6e652dc270