ACCENT, ACCENT RF, ENTITY, IDENTITY, IDENTITY ADX, IDENTITY XL, SUSTAIN XL, VERITY ADX XL, VERITY ADX XL M/S, VERITY ADX

FDA premarket approval P880086/S246 · decided 2014-09-04

Approval details

PMA number

P880086

Supplement

S246

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

ACCENT, ACCENT RF, ENTITY, IDENTITY, IDENTITY ADX, IDENTITY XL, SUSTAIN XL, VERITY ADX XL, VERITY ADX XL M/S, VERITY ADX

Generic name

Pulse generator, permanent, implantable

Applicant

ABBOTT MEDICAL

Date received

2014-08-07

Decision date

2014-09-04

Days to decision

28 days

Decision code

OK30

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

ALTERNATE SUPPLIER FOR THE HYBRID ASSEMBLY DIE COAT MATERIAL FOR THE DEVICES.

510(k) clearances by this applicant