SWEET PICOTIP(TM) RX STEROID ELUTING, POROUS TIP, POSITIVE FIXATION LEAD
FDA premarket approval P960006/S001 · decided 1999-04-09
Approval details
- PMA number
- P960006
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SWEET PICOTIP(TM) RX STEROID ELUTING, POROUS TIP, POSITIVE FIXATION LEAD
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 1998-10-02
- Decision date
- 1999-04-09
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for several new lead models: the SWEET PICOTIP(TM) Rx Models 4050, 4051, 4052, 4053, 4054, and 4055 Steroid Eluting, Positive-Fixation, Porous Tip Pacing Leads. These devices are indicated for chornic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator.
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