RELAY/DASH/STRIDE/DART PACING SYSTEMS
FDA premarket approval P910020/S014 · decided 1996-03-03
Approval details
- PMA number
- P910020
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RELAY/DASH/STRIDE/DART PACING SYSTEMS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 1996-02-01
- Decision date
- 1996-03-03
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE INTRODUCTION OF LABELING ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY THE FOLLOWING MODELS ARE AFFECTED:RELAY:293-03/294-03/294-03R -- DASH:291-03/292-03/292-03R -- STRIDE:294-05 -- DART:292-05 -- UNITY-C:292-06
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