PMA P960007S013

Device: TRANSCYTE
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S013
Product code: MGR
Decision date: 2000-03-16
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: Approval to extend the expiration date to 20 months and to revise product labeling to indicate that the device may be stored by the end user at temperatures between -70C and -20C.

Current openFDA PMA Record#

Device: TRANSCYTE
Applicant: Shire Regenerative Medicine
PMA number: P960007
Supplement: S013
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2000-03-16
Decision code: APPR
Date received: 1999-09-02
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to extend the expiration date to 20 months and to revise product labeling to indicate that the device may be stored by the end user at temperatures between -70C and -20C.