Human Lyophilized Dura Mater
LEM is the FDA product code for Human Lyophilized Dura Mater, a class II device type, regulated under 21 CFR 882.5975. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- LEM
- Device name
- Human Lyophilized Dura Mater
- FDA 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)."
- Regulation
- 21 CFR 882.5975
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code LEM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1992 | 2 |
Applicants with the most clearances
Product code LEM| Applicant | Clearances |
|---|---|
| Lifelink Foundation Tissue Bank | 1 |
| Pfrimmer-Viggo GmbH & Co. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code LEM.
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