PMA P000036S017

Device: DERMAGRAFT (HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE)
Applicant: Shire Regenerative Medicine
PMA number: P000036
Supplement: S017
Product code: MGR
Decision date: 2013-05-23
Generic name: Dressing, wound and burn, interactive
Approval order statement: QUALIFICATION OF ADDITIONAL SEEDING VESSELS, AND PROPOSED A CHANGE IN THE TYPE OF MATERIAL USED FOR THE TUBING AND MANIFOLD ASSEMBLY CONNECTOR FITTINGS.

Current openFDA PMA Record#

Device: DERMAGRAFT (HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE)
Applicant: Shire Regenerative Medicine
PMA number: P000036
Supplement: S017
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2013-05-23
Decision code: OK30
Date received: 2013-04-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: QUALIFICATION OF ADDITIONAL SEEDING VESSELS, AND PROPOSED A CHANGE IN THE TYPE OF MATERIAL USED FOR THE TUBING AND MANIFOLD ASSEMBLY CONNECTOR FITTINGS.