PMA P900033S051
- Device
- INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S051
- Product code
- MDD
- Decision date
- 2016-03-29
- Classification
- Device, Dermal Replacement
- Generic name
- Device, dermal replacement
- Approval order statement
- Approval for a change to the collagen processing equipment cleaning protocol.
Current openFDA PMA Record#
- Device
- INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S051
- Product code
- MDD
- Generic name
- Device, dermal replacement
- Decision date
- 2016-03-29
- Decision code
- APPR
- Date received
- 2015-08-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the collagen processing equipment cleaning protocol.