Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ADAPTA, RELIA, SENSIA, & VERSA |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S233 |
Date Received | 06/29/2011 |
Decision Date | 07/28/2011 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order 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 PROGRAMMABLE READ ONLY MEMORY (EEPROM) CYCLIC REDUNDANCY CHECK (CRC). |
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