IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
FDA premarket approval P150012 · decided 2016-04-25
Approval details
- PMA number
- P150012
- Trade name
- IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2015-03-03
- Decision date
- 2016-04-25
- Days to decision
- 419 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for The ImageReady MR Conditional Pacing System. The device is indicated for the treatment of the following conditions:1) Symptomatic paroxysmal or permanent second- or third-degree AV block;2) Symptomatic bilateral bundle branch block;3) Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [SA] block);4) Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some
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