Attesta DR MRI SureScan, L DR MRI SureScan, S DR MRI SureScan, SR MRI SureScan, Sphera DR MRI SureScan, L DR MRI SureSca

FDA premarket approval P980035/S522 · decided 2017-10-31

Approval details

PMA number

P980035

Supplement

S522

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Attesta DR MRI SureScan, L DR MRI SureScan, S DR MRI SureScan, SR MRI SureScan, Sphera DR MRI SureScan, L DR MRI SureSca

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

Date received

2017-10-06

Decision date

2017-10-31

Days to decision

25 days

Decision code

OK30

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

Implementation of the following previously accepted changes: modifications to heavy metal testing for silicone, additional vision system for inspection of final packaged devices, additional laser welder for use in manufacturing of the battery header subassembly, a change to the chemical used for the etch process for integrated circuit components, an update to the hybrid testing process, changes to the integrated circuit tests used for pacemaker devices, and an update to the software used in the

510(k) clearances by this applicant