PMA P880086S270

Device: Assurity Models PM1240, PM2240; Assurity+ Models PM1260, PM2260; Endurity Models PM1160, PM2160; Endurity Core Models CD
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S270
Product code: NVZ
Decision date: 2016-02-22
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: Implementation of a visual inspection criterion used during the manufacturing of the hybrid assemblies.

Current openFDA PMA Record#

Device: Assurity Models PM1240, PM2240; Assurity+ Models PM1260, PM2260; Endurity Models PM1160, PM2160; Endurity Core Models CD
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S270
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2016-02-22
Decision code: OK30
Date received: 2016-01-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a visual inspection criterion used during the manufacturing of the hybrid assemblies.