PMA P900033S031

Device: INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S031
Product code: MDD
Decision date: 2013-08-29
Classification: Device, Dermal Replacement
Generic name: Device, dermal replacement
Approval order statement: INCREASE IN THE SAMPLE SIZE FOR BACTERIAL ENDOTOXIN TESTING (BET) FOR ALL COLLAGEN PRODUCTS MANUFACTURED AT THE PLAINSBORO NEW JERSEY FACILITY AND AT THE ANASCO, PUERTO RICO LOCATION.

Current openFDA PMA Record#

Device: INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S031
Product code: MDD
Generic name: Device, dermal replacement
Decision date: 2013-08-29
Decision code: OK30
Date received: 2013-07-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: INCREASE IN THE SAMPLE SIZE FOR BACTERIAL ENDOTOXIN TESTING (BET) FOR ALL COLLAGEN PRODUCTS MANUFACTURED AT THE PLAINSBORO NEW JERSEY FACILITY AND AT THE ANASCO, PUERTO RICO LOCATION.