PMA P900033S114
- Device
- INTEGRA DERMAL REGENERATION TEMPLATE
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S114
- Product code
- MGR
- Decision date
- 2025-02-24
- Classification
- General, Plastic Surgery
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- removal of an in process biocompatibility test from Finished Goods testing
Current openFDA PMA Record#
- Device
- INTEGRA DERMAL REGENERATION TEMPLATE
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S114
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2025-02-24
- Decision code
- OK30
- Date received
- 2025-02-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of an in process biocompatibility test from Finished Goods testing