SELUTE PICOTIP STEROID ELUTING LEAD
FDA premarket approval P950001/S003 · decided 1998-04-08
Approval details
- PMA number
- P950001
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SELUTE PICOTIP STEROID ELUTING LEAD
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 1997-10-01
- Decision date
- 1998-04-08
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for: a) Selute(R) Picotip(TM) Steroid Eluting, Endocardial Pacing Lead Model 4030, 4031, 4032, 4033, 4034, and 4035 which are indicated for chronic pacing and asensing of the ventricle when used with a compatible pulse generator, and b) the use of the Cosmed of Illinois facility as an alternate sterilization site.
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