PMA P900033S041
- Device
- INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S041
- Product code
- MDD
- Decision date
- 2015-02-12
- Classification
- Device, Dermal Replacement
- Generic name
- Device, dermal replacement
- Approval order statement
- APPROVAL FOR CHANGES TO THE BIOBURDEN TESTING PROTOCOL FOR THE INTEGRA DERMAL REGENERATION TEMPLATE.
Current openFDA PMA Record#
- Device
- INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S041
- Product code
- MDD
- Generic name
- Device, dermal replacement
- Decision date
- 2015-02-12
- Decision code
- APPR
- Date received
- 2014-09-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO THE BIOBURDEN TESTING PROTOCOL FOR THE INTEGRA DERMAL REGENERATION TEMPLATE.