|
Device | ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS |
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 | S189 |
Date Received | 10/12/2010 |
Decision Date | 11/10/2010 |
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 CHANGES TO THE INCOMING INSPECTION PROCEDURES INCLUDING THE TYPE OF ANALYSIS PERFORMED AND THE LOCATION OF THE LABORATORY PERFORMING THE ANALYSIS. |