SWEET TIP(R) RX STEROID ELUTING LEAD
FDA premarket approval P960006 · decided 1998-10-02
Approval details
- PMA number
- P960006
- Trade name
- SWEET TIP(R) RX STEROID ELUTING LEAD
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 1996-03-04
- Decision date
- 1998-10-02
- Days to decision
- 942 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the SWEET TIP(R) Rx Models 4143, 4144, 4145, 4243, 4244, and 4245 steroid-eluting, positive-fixation, porous tip, pacing leads. These devices are indicated for chronic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.