← FDA Medical Device Classifications
Implanted Diaphragmatic/Phrenic Nerve Stimulator
GZE · Class III — High Risk (PMA approval required, life-sustaining) · Neurology · 21 CFR 882.5830
Classification
- FDA Product Code
GZE- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 882.5830
- Review panel
- AN
- Medical specialty
- Neurology
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown