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CDRH Transparency: 515 Program Initiative Project Status Update - Implantable Pacemaker Pulse Generator Step 3

Posted Jul 29 2011 12:00am
  • Step 1: FDA collects existing information
  • Step 2: FDA assesses the risks and benefits
  • Step 3: FDA issues proposed rule, which proposes classification of device type into Class I, II, or III
  • Step 4: FDA receives and reviews comments provided
  • Step 5: FDA issues final rule, which finalizes classification of device type into Class I, II, or III
Regulation NameCFRProduct CodesProject StatusMost Recent FR
Notice on Device
automated external defibrillator870.5310MKJ, NSAStep 2 Link
cardiovascular permanent pacemaker electrode870.3680(b)DTBStep 3 Link
cranial electrotherapy stimulator882.5800JXKStep 3 Link
electroconvulsive therapy device882.5940GXCStep 2 Link
endosseous dental implant (blade-form dental implants)872.3640(b)(2)NRQStep 2 Link
external cardiac compressor870.5200DRM, LIXStep 2 Link
external counter-pulsating device870.5225DRNStep 2 Link
external pacemaker pulse generator870.3600DTEStep 2 Link
female condom884.5330OBYStep 5 Link
hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis888.3330KWAStep 2 Link
hip joint metal/metal semi-constrained, with cemented acetabular component, prosthesis888.3320JDL, LTOStep 2 Link
implantable pacemaker pulse generator870.3610DSZ, DXYStep 3 Link
implanted blood access device876.5540(b)(1)MSDStep 2 Link
intra-aortic balloon and control system870.3535DSP, NKOStep 2 Link
iontophoresis device890.5525(b)EGJStep 2 Link
mandibular condyle prosthesis872.3960(c)2)NEIStep 2 Link
membrane lung for long-term pulmonary support (i.e., ECMO)868.5610BYSStep 2 Link
nonroller-type cardiopulmonary bypass blood pump870.4360KFMStep 2 Link
pacemaker programmers870.3700KRGStep 3 Link
pacemaker repair or replacement material870.3710KFJStep 5 Link
pedicle screw spinal system888.3070(b)(2)NKBStep 2 Link
shortwave diathermy890.5290(b)ILXStep 2 Link
sorbent hemoperfusion system876.5870FLDStep 2 Link
topical oxygen878.5650KPJStep 5 Link
transilluminator for breast evaluation892.1990LEKStep 4 Link
ventricular bypass device870.3545OKRStep 5 Link
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