← FDA Medical Device Classifications
Implanted Cerebellar Stimulator
GZA · Class III — High Risk (PMA approval required, life-sustaining) · Neurology · 21 CFR 882.5820
Classification
- FDA Product Code
GZA- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 882.5820
- Review panel
- NE
- Medical specialty
- Neurology
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
Call for pmas 9/26/84 per 49 fr 26574 on 6/28/84
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown