MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U
FDA premarket approval P820076/S019 · decided 1996-01-24
Approval details
- PMA number
- P820076
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Biotronik, Inc.
- Date received
- 1995-05-02
- Decision date
- 1996-01-24
- Days to decision
- 267 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR THE MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U
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510(k) clearances by this applicant
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