PMA P050023S014

Device: COROX OTW UP STEROID-ELUTING LEAD
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S014
Product code: MRM
Decision date: 2011-07-01
Classification: Defibrillator, Implantable, Dual-chamber
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: APPROVAL FOR A SECOND MANUFACTURER OF THE STEROID COLLAR, AND SECOND SOURCE OF DEXAMETHASONE ACETATE (DXA) USED FOR PRODUCTION OF THE STEROID COLLAR.

Current openFDA PMA Record#

Device: COROX OTW UP STEROID-ELUTING LEAD
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S014
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2011-07-01
Decision code: APPR
Date received: 2008-06-04
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A SECOND MANUFACTURER OF THE STEROID COLLAR, AND SECOND SOURCE OF DEXAMETHASONE ACETATE (DXA) USED FOR PRODUCTION OF THE STEROID COLLAR.