PMA P900033S053

Device: INTEGRA(R) DERMAL REGENERATION TEMPLATE, INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S053
Product code: MDD
Decision date: 2016-05-09
Classification: Device, Dermal Replacement
Generic name: Device, dermal replacement
Approval order statement: Approval of two new product sizes (i.e., 4cm x 4cm and 7cm x 7cm) and revised packaging that permits inclusion of a stapler and staples in the Integra Omnigraft Dermal Regeneration Matrix kit. The device, as modified, will be marketed under the trade name Omnigraft Dermal Regeneration Matrix.

Current openFDA PMA Record#

Device: INTEGRA(R) DERMAL REGENERATION TEMPLATE, INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S053
Product code: MDD
Generic name: Device, dermal replacement
Decision date: 2016-05-09
Decision code: APPR
Date received: 2015-11-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval of two new product sizes (i.e., 4cm x 4cm and 7cm x 7cm) and revised packaging that permits inclusion of a stapler and staples in the Integra Omnigraft Dermal Regeneration Matrix kit. The device, as modified, will be marketed under the trade name Omnigraft Dermal Regeneration Matrix.