DYE — Replacement Heart-Valve Class III
FDA product code DYE covers "Replacement Heart-Valve", a Class III medical device regulated under 21 CFR 870.3925. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants.
Classification Details
- Product Code
- DYE
- Device Class
- Class III
- Regulation Number
- 870.3925
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Definition
Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))