FLEXTEND FAMILY OF LEADS
FDA premarket approval P960006/S019 · decided 2005-12-08
Approval details
- PMA number
- P960006
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Trade name
- FLEXTEND FAMILY OF LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Boston Scientific
- Date received
- 2005-11-09
- Decision date
- 2005-12-08
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF A SECOND SUPPLIER FOR THE FLUORO RING COMPONENT USED FOR IDENTIFYING THE POSITION OF THE ELECTRODE DURING FLUOROSCOPY.
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