PMA P900033S081
- Device
- Integra Meshed Dermal Regeneration Template
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S081
- Product code
- MGR
- Decision date
- 2019-07-15
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- Qualification of an alternate manufacturing facility for Integra Meshed Dermal Regeneration Template.
Current openFDA PMA Record#
- Device
- Integra Meshed Dermal Regeneration Template
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S081
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2019-07-15
- Decision code
- OK30
- Date received
- 2019-06-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of an alternate manufacturing facility for Integra Meshed Dermal Regeneration Template.