PMA P900033S089
- Device
- Integra Dermal Regeneration Template
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S089
- Product code
- MGR
- Decision date
- 2020-09-04
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- Replacement of two Yokogawa paperless cycle recorders used in Lyophilizer's 1 and 2 in Integras manufacturing facility.
Current openFDA PMA Record#
- Device
- Integra Dermal Regeneration Template
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S089
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2020-09-04
- Decision code
- OK30
- Date received
- 2020-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of two Yokogawa paperless cycle recorders used in Lyophilizer's 1 and 2 in Integras manufacturing facility.