Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

FDA premarket approval P010015/S331 · decided 2017-06-13

Approval details

PMA number

P010015

Supplement

S331

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Generic name

Implantable pulse generator, pacemaker (non-CRT)

Applicant

Medtronic, Inc.

Date received

2017-05-15

Decision date

2017-06-13

Days to decision

29 days

Decision code

OK30

Product code

LWP

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

Align manufacturing of the Percepta, Solara, Serena and Astra IPGs with existing manufacturing of market approved devices by implementing a change to the monitoring frequency for the battery header laser weld inspection.

510(k) clearances by this applicant