INTEGRA ® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Rege
Integra Lifesciences Corp. · Dressing, wound and burn, interactive · General, Plastic Surgery
Open FDA's page for this record- PMA number
- P900033
- Supplement number
- S117
- Applicant
- Integra Lifesciences Corp.
- Street 1
- 105 Morgan Ln.
- City
- Plainsboro
- State
- NJ
- Zip
- 08536
- Generic name
- Dressing, wound and burn, interactive
- Trade name
- INTEGRA ® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Rege
- Product code
- MGR
- Advisory committee
- SU
- Advisory committee description
- General, Plastic Surgery
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-08-21
- Decision date
- 2026-09-18
- Decision code
- OK30
- Ao statement
- installation and qualification of a new Water for Injection (WFI) pretreatment, generation, storage, and distribution system
- Harmonized identifiers (openFDA)
- Device name
- Dressing, Wound And Burn, Interactive
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 2029275, 3008087383, 3009882464, 1121308, 3003418325, 1221816
- FEI number
- 3008087383, 3009882464, 1121308, 1000306431, 3003418325, 1000148471