ADAPTA, RELIA, SENSIA, & VERSA

FDA premarket approval P980035/S233 · decided 2011-07-28

Approval details

PMA number

P980035

Supplement

S233

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

ADAPTA, RELIA, SENSIA, & VERSA

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

Date received

2011-06-29

Decision date

2011-07-28

Days to decision

29 days

Decision code

OK30

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

FIVE CHANGES TO GEN2 HYBRID TESTER FINAL TEST SOLUTION: 1) UPDATE TO THE FORCE MEASURE_NGT2 MODULE; 2) UPDATE THE PULSE AMPLITUDE AND PULSE WIDTH TEST , PULSE AMPLITUDE 7500 MV AND AMPLITUDE 7500 MV TEST SEQUENCES; 3) WIDEN THE TOLERANCE OF THE STABILITY CHECK CRITERIA FOR THE PULSE AMPLITUDE AND PULSE WIDTH TEST ;4) UPDATE THE CONFIGURATION SETTINGS FOR THE PULSE AMPLITUDE 7500 MV AND UNIPOLAR BIPOLAR SWITCH TEST AND THE INTER-CHAMBER CROSSTALK TEST; AND 5) UPDATE THE ELECTRICALLY ERASABLE PROG

510(k) clearances by this applicant