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

FDA premarket approval P010015/S327 · decided 2017-06-04

Approval details

PMA number

P010015

Supplement

S327

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,Solar Bipolar CRT-P,

Generic name

Implantable pulse generator, pacemaker (non-CRT)

Applicant

Medtronic, Inc.

Date received

2017-05-10

Decision date

2017-06-04

Days to decision

25 days

Decision code

OK30

Product code

LWP

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

1) New supplier for material used in battery manufacturing; implementation of an update to FACTORYworks (FW) Release 9.3.; 2) updated test equipment for use in battery manufacturing; 3) changes to the acceptance parameter specification limits for certain wafers and associated process changes; 4) the addition of mixing equipment used in battery manufacturing; 5) an additional laser welder for use in battery manufacturing; and 6) changes to the manufacturing process flow at an integrated circuit c

510(k) clearances by this applicant