← FDA Medical Device Classifications
Device, Intrauterine, Contraceptive And Introducer
HDT · Class III — High Risk (PMA approval required, life-sustaining) · Obstetrics/Gynecology · 21 CFR 884.5360
Classification
- FDA Product Code
HDT- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 884.5360
- Review panel
- OB
- Medical specialty
- Obstetrics/Gynecology
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown