FLEXTEND FAMILY OF PACING LEADS
FDA premarket approval P960006/S016 · decided 2005-08-04
Approval details
- PMA number
- P960006
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FLEXTEND FAMILY OF PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2005-07-05
- Decision date
- 2005-08-04
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF PRIMER TO THE INNER SURFACE OF THE ELECTRODE RING OF THE FLEXTEND LEADS TO INCREASE ADHESION OF THE ELECTRODE RING TO THE MOLDED NECK.
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