ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM
FDA premarket approval P950037/S004 · decided 1998-09-24
Approval details
- PMA number
- P950037
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Biotronik, Inc.
- Date received
- 1998-08-31
- Decision date
- 1998-09-24
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- Approval for a slightly downsized header for the Actros DR, D, SR, and S pulse generators as well as approval for the Actros DR-A which is compatible with 5-mm leads and the Actros SR-B which is compatible with 6-mm leads. The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following: Actros DR, D, SR, S, DR-A, and SR-B models, PMS 1000 C programmers, SWM 1000 (Version F03.B00.U).
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