FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD
FDA premarket approval P960006/S008 · decided 2003-05-30
Approval details
- PMA number
- P960006
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2003-03-20
- Decision date
- 2003-05-30
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR CHANGE IN THE DUROMETER HARDNESS FROM 55D TO 70D.
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