PMA P140003S131

Device: Impella 5.5 with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S131
Product code: OZD
Decision date: 2025-10-01
Classification: Cardiovascular
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: a manufacturing process change to add a second Loctite 4062 glue application point between the connector cable and kink protector of the Impella 5.5 S2 pump handle

Current openFDA PMA Record#

Device: Impella 5.5 with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S131
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2025-10-01
Decision code: OK30
Date received: 2025-09-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a manufacturing process change to add a second Loctite 4062 glue application point between the connector cable and kink protector of the Impella 5.5 S2 pump handle