SWEET TIP RX, SWEET PICOTIP Rx, and FLEXTEND Pacing Lead Families
FDA premarket approval P960006/S046 · decided 2016-06-23
Approval details
- PMA number
- P960006
- Supplement
- S046
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SWEET TIP RX, SWEET PICOTIP Rx, and FLEXTEND Pacing Lead Families
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2016-05-27
- Decision date
- 2016-06-23
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Alternate sterilization recipe and addition of a new sterilization release mechanism.
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