MODEL 1256D META MV CARDIAC PULSE GENERATOR
FDA premarket approval P900070/S020 · decided 1997-10-07
Approval details
- PMA number
- P900070
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MODEL 1256D META MV CARDIAC PULSE GENERATOR
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
- Date received
- 1997-09-10
- Decision date
- 1997-10-07
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the change in companies from Telectronics to Pacesetter. The device, as modified, will be marketed under the brand name Pacesetter for the dual chamber pacing models of the META(TM) DDDR Model 1250H Pulse Generator (hereinafter referred to as the META(TM) DDDR) which is indicated where maintenance of atrio-ventricular synchrony is required. This requirement is associated with the generally accepted indication for permanaent cardiac pacing which includes, but are not limited to: 1) s
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