ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593
FDA premarket approval P010012/S160 · decided 2008-05-16
Approval details
- PMA number
- P010012
- Supplement
- S160
- Supplement type
- Normal 180 Day Track
- Trade name
- ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2007-10-09
- Decision date
- 2008-05-16
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ACUITY SPIRAL LEAD MODEL 4591, 4592, AND 4593. THE DEVICE IS INDICATED FOR CHRONIC, LEFT-VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR.
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