ISOFLEX S PERMANENT PACING LEAD MODELS
FDA premarket approval P960030/S010 · decided 2003-04-10
Approval details
- PMA number
- P960030
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ISOFLEX S PERMANENT PACING LEAD MODELS
- Generic name
- permanent pacemaker Electrode
- Applicant
- ABBOTT MEDICAL
- Date received
- 2003-02-11
- Decision date
- 2003-04-10
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR REDUCED LEAD BODY SIZE FOR THE PASSIVE PLUS DX LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ISOFLEX S AND IS INDICATED FOR USE IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR TO PROVIDE PERMANENT PACING AND SENSING IN EITHER THE ATRIUM (MODELS 1643K AND 1642T) OR VENTRICLE (MODELS 1645K AND 1646T).
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