Data / Medical devices / United States / Pramand LLC
Pramand LLC: FDA-registered device maker in Bedford, MA, United States, 2 PMA approvals
Pramand LLC is registered with the FDA (registration 3016980830) in Bedford, MA, United States. It lists 1 device type. The FDA files 2 PMA approvals under its listings, the newest dated February 14, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016980830
- Address
- 201 Burlington Road Suite 210, North Building, Bedford, MA, United States, 01730
- Owner or operator
- Pramand LLC (10078839)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 14, 2023
- Registered through
- 2027
- Brand names listed
- CraniSeal, SpineSeal Spine Sealant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sealant, Dural | NQR | 3 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 14, 2025 | P240027 | SpineSeal Spine Sealant | NQR | 5 | September 11, 2026 | accessdata.fda.gov |
| July 6, 2023 | P220014 | CraniSeal Dural Sealant | NQR | 13 | October 1, 2026 | accessdata.fda.gov |
Compare with other makers
Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.