PMA P900033S067
- Device
- Integra Dermal Regeneration Template
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S067
- Product code
- MGR
- Decision date
- 2018-01-02
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- Validation of the cleaning process for the Silastic Guides and Suture Bars.
Current openFDA PMA Record#
- Device
- Integra Dermal Regeneration Template
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S067
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2018-01-02
- Decision code
- OK30
- Date received
- 2017-12-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Validation of the cleaning process for the Silastic Guides and Suture Bars.