MICClass II
Implant, Muscle, Pectoralis
21 CFR 874.3620 / Ear, Nose, Throat
MIC is the FDA product code for Implant, Muscle, Pectoralis, a class II device type, regulated under 21 CFR 874.3620. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- MIC
- Device name
- Implant, Muscle, Pectoralis
- Regulation
- 21 CFR 874.3620
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 8
- Ingested recalls
- 1
Clearances, product code MIC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 2000 | 1 |
| 2002 | 1 |
Applicants with the most clearances
Product code MIC| Applicant | Clearances |
|---|---|
| Seare Biomedical Corp. | 2 |
| Aesthetic and Reconstructive Technologies, Inc. | 1 |
| Applied Biomaterial Technologies | 1 |
| Hanson Medical, Inc. | 1 |
| Pillar Surgical, Inc. | 1 |
| Rand Scientific Corp. | 1 |
| Spectrum Designs, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
