PMA P100009S034

Device: MitraClip NT, NTR, XTR, G4 Clip Delivery System
Applicant: ABBOTT MEDICAL
PMA number: P100009
Supplement: S034
Product code: NKM
Decision date: 2019-08-30
Classification: Mitral Valve Repair Devices
Generic name: Mitral valve repair devices
Approval order statement: Approval for manufacturing process changes to reduce Clip Arm spread variability and to implement an inspection for final Clip Arm spread.

Current openFDA PMA Record#

Device: MitraClip NT, NTR, XTR, G4 Clip Delivery System
Applicant: ABBOTT MEDICAL
PMA number: P100009
Supplement: S034
Product code: NKM
Generic name: Mitral valve repair devices
Decision date: 2019-08-30
Decision code: APPR
Date received: 2019-08-06
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for manufacturing process changes to reduce Clip Arm spread variability and to implement an inspection for final Clip Arm spread.