# P900033: Integra Dermal Regeneration Template

- Pathway: PMA
- Applicant: Integra Lifesciences Corp.
- Decided: Mar 1, 1996 after 2,125 days
- Product code: MGR (Dressing, Wound And Burn, Interactive)
- Device class: 3
- Recalls of this device: 2 (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
- Jan 16, 2009 · Not classified · Z-1035-2009: Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.
- Jul 2, 2008 · Not classified · Z-2328-2008: Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010.

Source page: https://510kreport.com/device/P900033
Methodology: https://510kreport.com/methodology