FDA product code LEM: Human Lyophilized Dura Mater
LEM is the FDA product code for human lyophilized dura mater. It is a Class II device, regulated under 21 CFR 882.5975 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under LEM, from 2 different applicants. The average 510(k) review took 473 days (median 473).
Definition
Cber review required - previously regulated as a device under 21 cfr 882.5975, now regulated in cber under section 361 as banked human tissue. See definition at §1271.3(d). Subject to donor eligibility, good tissue practice, registration and listing requirements under part 1271" the good tissue practice regulation http://www.Fda.Gov/cber/rules/gtp.Pdf became final effective may 25, 2005. It states that "on january 27, 2004, fda issued an interim final rule excepting human dura mater and human heart valve allografts from the definition of hct/p in § 1271.3(d) (69 fr 3823). Fda stated that, when the comprehensive framework is in place, fda intends that human dura mater and human heart valves will be subject to it, and that fda intends to revoke the interim rule at that time (69 fr 3823 and 3824). With the effective date of this final rule, fda is revoking the interim rule and revising the language in § 1271.3(d)."
Classification
| Field | Value |
|---|---|
| Device name | Human Lyophilized Dura Mater |
| Device class | Class II |
| Regulation | 21 CFR 882.5975 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LEM clearance
Top LEM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lifelink Foundation Tissue Bank | 1 | 1992-06-09 |
| Pfrimmer-Viggo GmbH & Co. | 1 | 1992-04-20 |
Most recent LEM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K910447 | Lifelink Foundation Tissue Bank | DURA MATER | 1992-06-09 | 508 |
| K910555 | Pfrimmer-Viggo GmbH & Co. | TUTOPLAST DURA | 1992-04-20 | 438 |
Recalls for LEM devices
openFDA lists no recalls for product code LEM.
Frequently asked questions
What is FDA product code LEM?
LEM is the FDA product code for human lyophilized dura mater. It is a Class II device, regulated under 21 CFR 882.5975 and reviewed by the Neurology panel.
What device class is LEM?
Class II, regulation 21 CFR 882.5975. Typical premarket route: 510(k).
How long does a 510(k) take for product code LEM?
Across 2 cleared submissions the average was 473 days from receipt to decision (median 473).
Which companies have the most LEM clearances?
Lifelink Foundation Tissue Bank (1); Pfrimmer-Viggo GmbH & Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LEM
- Run a recall and safety report across every LEM manufacturer
- Watch product code LEM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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