# P820075: Lamicel (TM)

- Pathway: PMA
- Applicant: Medtronic Xomed, Inc.
- Decided: Jun 21, 1983 after 257 days
- Product code: LOB (Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination)
- Device class: 3
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 13, 2019 · Class II · Z-0733-2020: Routine sterilization dose does not meet the required Sterility Assurance Level.
- Nov 13, 2019 · Class II · Z-0734-2020: Routine sterilization dose does not meet the required Sterility Assurance Level.
- Nov 13, 2019 · Class II · Z-0735-2020: Routine sterilization dose does not meet the required Sterility Assurance Level.

Source page: https://510kreport.com/device/P820075
Methodology: https://510kreport.com/methodology